ERGOCALCIFEROL capsule

1. No Title 1572546765
2. No Title 1572548265
3. No Title 1572548864
4. No Title 1572551236
5. No Title 1572552831
6. No Title 1572554151
7. Indications And Usage
8. Dosage And Administration
9. Package Label.principal Display Panel
10. Packaging Information
11. Package/label Display Panel Carton 1.25 Mg
12. Package/label Display Panel Blister 1.25 Mg
13. No Title 1572447983
14. Description
15. Clinical Pharmacology
16. Indications And Usage
17. Contraindications
18. Warnings
19. Precautions
20. Adverse Reactions
21. Overdosage
22. Dosage And Administration
23. How Supplied
24. Principal Display Panel - 1.25 Mg Bottle Label
25. Vitamin D (ergocalciferol Capsules, Usp) 1.25 Mg (50,000 Usp Units)
26. Ergocalciferol
27. Vitamin D,ergocalciferolcapsules, Usp,1.25 Mg Softgel Capsules(soft Gelatin Capsules)(50,000 Usp Units)
28. Repackaging Information
29. Principal Display Panel - 1.25 Mg
30. No Title 1572450762
31. Packaging Information
32. Principal Display Panel - 1.25 Mg Capsule Bottle Label
33. No Title 1572452892
34. Principal Display Panel
35. No Title 1572454915
36. Principal Display Panel - 1.25 Mg
37. No Title 1572455203
38. No Title 1572448627

No Title 1572546765 ⮝

Rx Only

No Title 1572548265 ⮝

Manufactured by: Swiss Caps AG
Kirchberg, Switzerland
Distributed by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Rev. 04/09

No Title 1572548864 ⮝

Rx Only

No Title 1572551236 ⮝

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-3748(NDC:51991-604) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Gelatin, Unspecified (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Soybean Oil (UNII: 241ATL177A)

Product Characteristics Color GREEN Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-3748-1 12 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 2 NDC:63629-3748-4 4 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 3 NDC:63629-3748-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 4 NDC:63629-3748-3 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 5 NDC:63629-3748-5 20 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 6 NDC:63629-3748-6 8 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 7 NDC:63629-3748-7 15 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 8 NDC:63629-3748-8 120 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 9 NDC:63629-3748-9 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 10 NDC:63629-3748-0 45 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 08/17/2009

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-3748) , RELABEL(63629-3748)

Revised: 9/2018 Document Id: 41b16f53-ca9f-48d7-aaff-50ac394d6a1c 34391-3 Set id: b0e4452c-95a7-f70a-d9be-59e708dc7822 Version: 1006 Effective Time: 20180907 Bryant Ranch Prepack

No Title 1572552831 ⮝

Manufactured by: Swiss Caps AG
Kirchberg, Switzerland
Distributed by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

Rev. 04/09

No Title 1572554151 ⮝

Manufactured by: Swiss Caps AG
Kirchberg, Switzerland
Distributed by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Rev. 04/09

Indications And Usage ⮝

Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Dosage And Administration ⮝

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six times per day.

DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

Package Label.principal Display Panel ⮝

62332-464-31
Vitamin D
(Ergocalciferol
Capsules, USP)
1.25 mg*
(50,000 USP Units)
Rx only
100 Softgel Capsules
Alembic

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-464 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Gelatin, Unspecified (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Soybean Oil (UNII: 241ATL177A)

Product Characteristics Color GREEN Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62332-464-31 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 04/30/2018

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Caps AG		481784895	MANUFACTURE(62332-464)

Revised: 10/2019 Document Id: aaae9b89-61fe-425d-a0b4-10acc77ca528 34391-3 Set id: 87e80b1f-e376-45ba-825b-a6fda4b82325 Version: 3 Effective Time: 20191010 Alembic Pharmaceuticals Inc.

Packaging Information  ⮝

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Breckenridge Pharmaceutical, Inc. as follows:

(1.25 mg / 100 UD) NDC 68084-463-01 packaged from NDC 51991-604

Distributed by:

American Health Packaging

Columbus, Ohio 43217

8246301/0118

Package/label Display Panel Carton 1.25 Mg ⮝

NDC 60687- 500-01

Vitamin D
(Ergocalciferol Capsules, USP)

1.25 mg*
(50,000 USP Units)

100 Capsules (10 x 10) Rx Only

* Each Softgel (Soft Gelatin Capsule) contains:
Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP
Units. One USP Unit of Vitamin D2 is equivalent to one
International Unit (IU).

Usual Dosage: See package insert for full prescribing
information.

WARNING: DO NOT EXCEED RECOMMENDED DOSAGE.

Store at 20 to 25 C (68 to 77 F); excursions permitted between
15 to 30 C (59 to 86 F) [see USP Controlled Room
Temperature]. Protect from light and moisture.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 62332-464, Alembic Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

750001
0450001/0419

Package/label Display Panel Blister 1.25 Mg ⮝

Vitamin D (Ergocalciferol
Capsule, USP)

1.25 mg (50,000 USP Units)

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-500(NDC:62332-464) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SOYBEAN OIL (UNII: 241ATL177A)

Product Characteristics Color green Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-500-01 100 in 1 BOX, UNIT-DOSE 05/01/2019 1 NDC:60687-500-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 05/01/2019

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(60687-500)

Revised: 4/2019 Document Id: 876fef38-0e7e-e076-e053-2a95a90a3565 34391-3 Set id: 5656d41e-4324-48ee-961b-883508a4dd4f Version: 1 Effective Time: 20190426 American Health Packaging

No Title 1572447983 ⮝

Rx Only

Description ⮝

Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration.

Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity.

There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity.

One USP Unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU.

Each softgel capsule, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil.

Ergocalciferol, also called vitamin D2 ,is 9, 10-secoergosta-5, 7,10(19),22-tetraen-3-ol,(3 ,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula:

Inactive Ingredients: D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil.

Clinical Pharmacology ⮝

The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxy- vitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.

There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.

Indications And Usage ⮝

Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Contraindications ⮝

Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Warnings ⮝

Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted.

Keep out of the reach of children.

Precautions ⮝

General

Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as there is clinical improvement. Dosage levels must be individualized and great care exercised to prevent serious toxic effects. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with frequent blood calcium determinations.

In the treatment of hypoparathyroidism, intravenous calcium, parathyroid hormone, and/or dihydrotachysterol may be required.

Maintenance of a normal serum phosphorous level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal osteodystrophy is essential to prevent metastatic calcification.

Adequate dietary calcium is necessary for clinical response to vitamin D therapy.

Protect from light.

Drug Interactions

Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations. Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the drug's potential in these areas.

Pregnancy Category C

Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP units of vitamin D daily during pregnancy has not been established.

Nursing Mothers

Caution should be exercised when ergocalciferol is administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infant's serum calcium concentration is required in that case (Goldberg, 1972).

Pediatric Use

Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies of ergocalciferol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A few published reports have suggested that the absorption of orally administered vitamin D may be attenuated in elderly compared to younger individuals. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions ⮝

Hypervitaminosis D is characterized by effects on the following organ system:

Renal: Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death.

CNS: Mental retardation.

Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs.

Skeletal: Bone demineralization (osteoporosis) in adults occurs concomitantly.
Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism), vague aches, stiffness, and weakness.

Gastrointestinal: Nausea, anorexia, constipation.

Metabolic: Mild acidosis, anemia, weight loss.

Overdosage ⮝

The effects of administered vitamin D can persist for two or more months after cessation of treatment.

Hypervitaminosis D is characterized by:

1.

Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis.

2.

Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death.

3.

Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Bone demineralization (osteoporosis) in adults occurs concomitantly.

4.

Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism).

The treatment of hypervitaminosis D with hypercalcemia consists of immediate withdrawal of the vitamin, a low calcium diet, generous intake of fluids, along with symptomatic and supportive treatment. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia requires more vigorous treatment. The first step should be hydration of the patient. Intravenous saline may quickly and significantly increase urinary calcium excretion. A loop diuretic (furosemide or ethacrynic acid) may be given with the saline infusion to further increase renal calcium excretion. Other reported therapeutic measures include dialysis or the administration of citrates, sulfates, phosphates, corticosteroids, EDTA (ethylenediaminetetraacetic acid), and mithramycin via appropriate regimens. With appropriate therapy, recovery is the usual outcome when no permanent damage has occurred. Deaths via renal or cardiovascular failure have been reported.

The LD50 in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.

Dosage And Administration ⮝

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six times per day.

DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

How Supplied ⮝

Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP.

Bottles of 12 Softgel Capsules (NDC 60429-245-12)
Bottles of 13 Softgel Capsules (NDC 60429-245-13)
Bottles of 100 Softgel Capsules (NDC 60429-245-01)

Storage and Handling

Store at 20 25 C (68 77 F) [See USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by: Swiss Caps AG Kirchberg, Switzerland

Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487

Marketed/Packaged by: GSMS Inc. Camarillo, CA 93012

Rev. 04/09

Principal Display Panel - 1.25 Mg Bottle Label ⮝

Blenheim Pharmacal, Inc.

NDC 10544-527-12

Vitamin D
(Ergocalciferol Capsules, USP)

1.25 mg*

(50,000 USP Units)

Rx Only

12 Softgel Capsules

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-527(NDC:51991-604) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SOYBEAN OIL (UNII: 241ATL177A)

Product Characteristics Color green Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10544-527-08 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/03/2014 2 NDC:10544-527-12 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/03/2014

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 10/02/2013

Labeler - Blenheim Pharmacal, Inc. (171434587)

Registrant - Blenheim Pharmacal, Inc. (171434587)

Establishment
Name	Address	ID/FEI	Business Operations
Blenheim Pharmacal, Inc.		171434587	repack(10544-527)

Revised: 2/2015 Document Id: 0fefb3a2-f0c7-0544-e054-00144ff8d46c 34391-3 Set id: 0fefb3a2-f0c6-0544-e054-00144ff8d46c Version: 1 Effective Time: 20150225 Blenheim Pharmacal, Inc.

Vitamin D (ergocalciferol Capsules, Usp) 1.25 Mg (50,000 Usp Units) ⮝

Rx Only

Ergocalciferol ⮝

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2083(NDC:51991-604) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Gelatin, Unspecified (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Soybean Oil (UNII: 241ATL177A)

Product Characteristics Color GREEN Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2083-3 12 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2015 2 NDC:50090-2083-1 8 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2015 3 NDC:50090-2083-2 4 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2015

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 08/17/2009

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-2083) , REPACK(50090-2083)

Revised: 12/2017 Document Id: 57443e83-1e03-434f-936b-787d1f1dc542 34391-3 Set id: 8a3d5737-02a2-492e-be50-42aa9d7b02e2 Version: 5 Effective Time: 20171229 A-S Medication Solutions

Vitamin D,ergocalciferolcapsules, Usp,1.25 Mg Softgel Capsules(soft Gelatin Capsules)(50,000 Usp Units)  ⮝

Rx Only

Repackaging Information ⮝

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	1.25 mg
3	43353-219-03
4	43353-219-04
8	43353-219-08

Store between 20 -25 C (68 -77 F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20170901JH

Principal Display Panel - 1.25 Mg  ⮝

NDC 43353-219-03

Vitamin D
(Ergocalciferol Capsules, USP)

1.25 mg*

(50,000 USP Units)

Rx Only

3 Softgel Capsules

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-219(NDC:60429-245) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC) Ergocalciferol 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Gelatin (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Soybean Oil (UNII: 241ATL177A)

Product Characteristics Color GREEN Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43353-219-03 3 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2017 2 NDC:43353-219-04 4 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2017 3 NDC:43353-219-08 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/25/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 11/15/2011

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(43353-219)

Revised: 10/2017 Document Id: 7d5d42ee-0533-4ade-9d04-8a58ec77b8f7 34391-3 Set id: 4bedecb7-8c37-4a1c-81f6-0adfed636f37 Version: 2 Effective Time: 20171011 Aphena Pharma Solutions - Tennessee, LLC

No Title 1572450762 ⮝

Rx Only

Packaging Information ⮝

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Alembic Pharmaceuticals, Inc. as follows:
(1.25 mg / 100 UD) NDC 60687-500-01 packaged from NDC 62332-464

Distributed by:
American Health Packaging
Columbus, OH 43217

8450001/0419

Principal Display Panel - 1.25 Mg Capsule Bottle Label ⮝

NDC 51991-604-01

Vitamin D
(Ergocalciferol
Capsules, USP)

1.25 mg*

100 Softgel
Capsules

(50,000 USP Units)
Rx Only

Breckenridge
Pharmaceutical, Inc.

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51991-604 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC) Ergocalciferol 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Gelatin, Unspecified (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Soybean Oil (UNII: 241ATL177A)

Product Characteristics Color GREEN Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51991-604-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/17/2009 10/31/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 08/17/2009 10/31/2019

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Registrant - Orit Laboratories LLC (167618912)

Establishment
Name	Address	ID/FEI	Business Operations
Orit Laboratories LLC		167618912	ANALYSIS(51991-604)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Caps		481784895	MANUFACTURE(51991-604)

Revised: 9/2018 Document Id: 46db4e66-96a9-4170-b637-a74514ec9fec 34391-3 Set id: f1b24841-75a3-4eb8-8854-17ce832ff09d Version: 3 Effective Time: 20180905 Breckenridge Pharmaceutical, Inc.

No Title 1572452892 ⮝

Rx Only

Principal Display Panel ⮝

NDC 66336-0907-XX
NDC 66336-0907-06
NDC 66336-0907-44

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66336-907(NDC:51991-604) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC) Ergocalciferol 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Gelatin (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Soybean Oil (UNII: 241ATL177A)

Product Characteristics Color green Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66336-907-06 6 in 1 BOTTLE 2 NDC:66336-907-44 4 in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 08/17/2009

Labeler - Dispensing Solutions, Inc. (066070785)

Registrant - PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Business Operations
Dispensing Solutions, Inc.		066070785	relabel, repack

Revised: 2/2012 Document Id: 553f273b-5017-4e27-bf7c-7828a5f74c54 34391-3 Set id: 0525e04f-91b7-4d75-8ff9-a6fb5705d993 Version: 1 Effective Time: 20120206 Dispensing Solutions, Inc.

No Title 1572454915 ⮝

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-3748(NDC:51991-604) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Gelatin, Unspecified (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Soybean Oil (UNII: 241ATL177A)

Product Characteristics Color GREEN Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-3748-1 12 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 2 NDC:63629-3748-4 4 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 3 NDC:63629-3748-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 4 NDC:63629-3748-3 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010 5 NDC:63629-3748-5 20 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 6 NDC:63629-3748-6 8 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 7 NDC:63629-3748-7 15 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 8 NDC:63629-3748-8 120 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 9 NDC:63629-3748-9 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/17/2009 10 NDC:63629-3748-0 45 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 08/17/2009

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-3748) , RELABEL(63629-3748)

Revised: 9/2018 Document Id: 41b16f53-ca9f-48d7-aaff-50ac394d6a1c 34391-3 Set id: b0e4452c-95a7-f70a-d9be-59e708dc7822 Version: 1006 Effective Time: 20180907 Bryant Ranch Prepack

Principal Display Panel - 1.25 Mg ⮝

NDC 71610-240 - Vitamin D (Ergocalciferol), USP 1.25 mg (50,000 USP Units) Capsules - Rx Only

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-240(NDC:51407-143) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SOYBEAN OIL (UNII: 241ATL177A)

Product Characteristics Color green Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-240-04 4 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2019 2 NDC:71610-240-12 12 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 05/20/2009

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-240)

Revised: 2/2019 Document Id: 39698c46-7643-4c67-bdcf-b7b081e29481 34391-3 Set id: 244b5ce5-fe1b-487d-adab-2733a8a61d51 Version: 1 Effective Time: 20190226 Aphena Pharma Solutions - Tennessee, LLC

No Title 1572455203 ⮝

Rx Only

No Title 1572448627 ⮝

Rx Only