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Eteplirsen NDCs, Package Codes, Strengths & Labelers

This page lists NDC package records for Eteplirsen products — strengths, dosage forms, package sizes, labelers, 11-digit billing NDCs, pricing data when available, and links to each individual NDC page. It’s an NDC/package & billing directory, not a clinical drug page.

Key stats

6
Package NDCs
5
Products
5
Active listings
0
Discontinued
3
Labelers
4
Strengths
2
Dosage forms
0
With NADAC pricing

By strength, form & labeler

NDC products by strength
ETEPLIRSEN 50 mg/mL 2
ETEPLIRSEN 100 mg/2mL 1
ETEPLIRSEN 1 g/g 1
ETEPLIRSEN 500 mg/10mL 1
By dosage form
INJECTION 4
POWDER 1
Top labelers
Catalent Indiana, LLC 2
Sarepta Therapeutics, Inc. 2
Polypeptide Laboratories Inc 1

Browse records — 5 products

Drug / product Billing NDC NADAC / unit Status
eteplirsen 100 mg/2mL INJECTION Catalent · NDC 61434-0003-01 · 352 VIAL in 1 CASE (61434-003-01) / 2 mL in 1 VIAL 61434-0003-01 — On market View →
ETEPLIRSEN 1 g/g POWDER Polypeptide · NDC 63557-2072-01 · 400 g in 1 BOTTLE, GLASS (63557-2072-1) 63557-2072-01 — On market View →
eteplirsen 500 mg/10mL INJECTION Catalent · NDC 61434-0035-01 · 288 VIAL in 1 CASE (61434-035-01) / 10 mL in 1 VIAL 61434-0035-01 — On market View →
Exondys 51 eteplirsen 50 mg/mL INJECTION Sarepta · NDC 60923-0284-10 · 1 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) / 10 mL in 1 VIAL, SINGLE-USE 60923-0284-10 — On market View →
Exondys 51 eteplirsen 50 mg/mL INJECTION Sarepta · NDC 60923-0363-02 · 1 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) / 2 mL in 1 VIAL, SINGLE-USE 60923-0363-02 — On market View →
Where does this data come from?
NDC package records, strengths, forms and labelers come from the openFDA NDC Directory; pricing is CMS NADAC. Grouped by active-ingredient name. This is package/billing reference data, not clinical drug information.