NDC 60923-363

Exondys 51

Eteplirsen

Exondys 51 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sarepta Therapeutics, Inc.. The primary component is Eteplirsen.

• Product ID: 60923-363_362947a6-d00c-471c-8c5e-14e59fd325f8
• NDC: 60923-363
• Product Type: Human Prescription Drug
• Proprietary Name: Exondys 51
• Generic Name: Eteplirsen
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-09-19
• Marketing Category: NDA / NDA
• Application Number: NDA206488
• Labeler Name: Sarepta Therapeutics, Inc.
• Substance Name: ETEPLIRSEN
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 60923-363-02

1 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) > 2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60923-363-02 [60923036302]

Exondys 51 INJECTION

• Marketing Category: NDA
• Application Number: NDA206488
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-09-19
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-18

Drug Details

Active Ingredients

Ingredient	Strength
ETEPLIRSEN	50 mg/mL

OpenFDA Data

• SPL SET ID: 33bff678-7829-479e-9110-b8e33a0bc0aa
• Manufacturer:
  • Sarepta Therapeutics, Inc.
• UNII:
  • AIW6036FAS
• RxNorm Concept Unique ID - RxCUI:
  • 1810582
  • 1810581
  • 1810573
  • 1810578
• UPC Code:
  • 0360923363027
  • 0360923284100

Pharmacological Class

• Antisense Oligonucleotide [EPC]
• Oligonucleotides
• Antisense [CS]

NDC Crossover Matching brand name "Exondys 51" or generic name "Eteplirsen"

NDC	Brand Name	Generic Name
60923-284	Exondys 51	eteplirsen
60923-363	Exondys 51	eteplirsen