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EXONDYS 51- eteplirsen injection


  1. Patient Information
  2. Single Dose. Mfg For:
  3. Revised: 10/2018document Id:

Patient Information 

Hypersensitivity Reactions

Advise patients and/or caregivers that symptoms of hypersensitivity, including bronchospasm and hypotension, can occur with EXONDYS 51. Instruct them to seek immediate medical care should they experience signs and symptoms of hypersensitivity[see Warnings and Precautions (5.1)].

Manufactured for:
Sarepta Therapeutics, Inc.
Cambridge, MA 02142 USA

Principal Display Panel - Carton Label

NDC: 60923-363-02

Rx Only

Exondys 51
(eteplirsen) Injection

100 mg/2 mL

(50 mg/mL)

For Intravenous Infusion
After Dilution

Single Dose

1 vial

SAREPTA
THERAPEUTICS

Principal Display Panel - Carton Label

Principal Display Panel - Vial Label

NDC 60923-363-02

EXONDYS 51
(eteplirsen) Injection

100 mg/2 mL (50 mg/mL)

Single Dose. Mfg For: 

Sarepta Therapeutics, Inc.

Cambridge, MA 02142 USA

Principal Display Panel - Vial Label

Principal Display Panel - Carton Label

NDC: 60923-284-10

Rx Only

Exondys 51
(eteplirsen) Injection

500 mg/10 mL

(50 mg/mL)

For Intravenous Infusion
After Dilution

Single Dose

1 vial

SAREPTA
THERAPEUTICS

Principal Display Panel - Carton Label

Principal Display Panel - Vial Label

NDC 60923-284-10

EXONDYS 51Rx Only

(eteplirsen) Injection Single Dose

500 mg/10 mL (50 mg/mL)

For Intravenous Infusion After Dilution

Refrigerate at 2C-8C (36F-46F).

Mfg for: Sarepta Therapeutics, Inc.

Cambridge, MA 02142 USA

Principal Display Panel - Vial Label
EXONDYS 51
eteplirsen injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60923-363
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
eteplirsen(UNII: AIW6036FAS) (eteplirsen - UNII:AIW6036FAS)eteplirsen50 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium chloride(UNII: 451W47IQ8X)
potassium chloride(UNII: 660YQ98I10)
potassium phosphate, monobasic(UNII: 4J9FJ0HL51)
sodium phosphate, dibasic, anhydrous(UNII: 22ADO53M6F)
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60923-363-021 in 1 CARTON09/19/2016
12 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20648809/19/2016
EXONDYS 51
eteplirsen injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60923-284
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
eteplirsen(UNII: AIW6036FAS) (eteplirsen - UNII:AIW6036FAS)eteplirsen50 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium chloride(UNII: 451W47IQ8X)
potassium chloride(UNII: 660YQ98I10)
potassium phosphate, monobasic(UNII: 4J9FJ0HL51)
sodium phosphate, dibasic, anhydrous(UNII: 22ADO53M6F)
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60923-284-101 in 1 CARTON09/19/2016
110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20648809/19/2016
Labeler -Sarepta Therapeutics, Inc. (121653406)

Revised: 10/2018document Id: 

fc67efb3-d13d-4d99-9c8f-ff05caa95eacSet id: 33bff678-7829-479e-9110-b8e33a0bc0aaVersion: 5Effective Time: 20181022Sarepta Therapeutics, Inc.



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