Patient Information ⮝
- Inform patients that generalized allergic reactions have been reported with glucagon treatment including generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. Advise patients to monitor and report any signs or symptoms of a hypersensitivity reaction[seeWarnings and Precautions (5.5)].
- Inform patients that hypoglycemia has occurred with treatment with glucagon. Inform patients of the symptoms of hypoglycemia and how to treat it. Advise patients to avoid driving or operating machinery until ingesting a meal. Advise patients to inform their health care provider if hypoglycemia occurs so that treatment may be given if necessary[seeAdverse Reactions (6)].
- Inform patients with diabetes mellitus that treatment with Glucagon for Injection may increase their risk of hyperglycemia[see Warnings and Precautions (5.3)].
- Inform patients with cardiac disease that treatment with Glucagon for Injection may increase their risk of a transient increase in blood pressure and heart rate[see Warnings and Precautions (5.4)].
NOVAPLUS is a registered trademark of Vizient, Inc.
Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047
www.fresenius-kabi.us451462A
PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Label
NP509613
Glucagon for Injection
1 mg per vial
For intramuscular or intravenous injection.
For diagnostic use only.
Reconstitute with Sterile Water for Injection, USPRx only
PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Tray Label
63323-596-16Glucagon for Injection
For intramuscular or intravenous injection only.
1 mg per vial
For diagnostic use only.
10 Single Dose VialsRx only
PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mg Vial Label
NP509603
Glucagon for Injection
1 mg per vial
For intramuscular or intravenous injection.
For diagnostic use only.
Reconstitute with Sterile Water for Injection, USP Rx only
PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mL Diluent Vial Label
Sterile Waterfor Injection, USP
1 mL per vial
FOR DRUG DILUENT USE ONLYContains no antimicrobial or other added substance.
Do not give intravenously unless rendered nearly Isotonic.
Discard unused portion.
1 mLSingle Dose Vial Rx only
PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon Kit 1 mg Vial Carton Panel
Glucagon for Injection
For intramuscular or intravenous injection only.
1 mg per vial
FOR DIAGNOSTIC USE ONLY.
Reconstitute with Sterile Water for Injection, USP immediately
before use.
Each Kit Contains: ⮝
- One single dose vial with 1 mg of Glucagon for Injection
- One single dose vial with 1 mL of Sterile Water for Injection, USP
Single Dose Vials
Rx only
GLUCAGON
glucagon injection, powder, lyophilized, for solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-596 Route of Administration INTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLUCAGON HYDROCHLORIDE(UNII: 1H87NVF4DB) (GLUCAGON - UNII:76LA80IG2G) GLUCAGON 1 mg in 1 mL
Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X) HYDROCHLORIC ACID(UNII: QTT17582CB) SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63323-596-16 10 in 1 TRAY 05/08/2015 1 NDC:63323-596-08 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA201849 05/08/2015
GLUCAGON
glucagon kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-594
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63323-594-03 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 12/01/2015
Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-USE 1 mL Part 2 1 VIAL, SINGLE-USE 1 mL
Part 1 of 2 GLUCAGON
glucagon injection, powder, lyophilized, for solution
Product Information Item Code (Source) NDC:63323-596 Route of Administration INTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLUCAGON HYDROCHLORIDE(UNII: 1H87NVF4DB) (GLUCAGON - UNII:76LA80IG2G) GLUCAGON 1 mg in 1 mL
Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X) HYDROCHLORIC ACID(UNII: QTT17582CB) SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63323-596-06 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA201849 05/08/2015
Part 2 of 2 WATER
sterile water injection
Product Information Item Code (Source) NDC:63323-185 Route of Administration INTRAVENOUS, INTRAMUSCULAR
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER(UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 1 mg in 1 mL
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63323-185-03 1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088400 11/23/2015
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA201849 12/01/2015
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment Name Address ID/FEI Business Operations Fresenius Kabi USA, LLC 023648251 manufacture(63323-594, 63323-596)
Revised: 5/2019document Id: ⮝
897c7bb7-5a0a-7576-e053-2a95a90a894eSet id: 8c8acad6-44cc-43aa-966b-027e053be8f5Version: 3Effective Time: 20190522Fresenius Kabi USA, LLC