Exondys 51
- Product NDC
- 60923-284
- 11-digit product format
- 609230284
- Labeler code
- 60923
- Product ID
- 60923-284_97565339-f295-43ab-98a9-bb6bdf2d049c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eteplirsen
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sarepta Therapeutics, Inc.
- Application
- NDA206488
- Marketing category
- NDA
- Marketing start
- 2016-09-19
- Substance
- ETEPLIRSEN
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Antisense Oligonucleotide [EPC], Oligonucleotides, Antisense [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Exondys 51
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETEPLIRSEN | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AIW6036FAS |
| Rxcui | 1810573, 1810578, 1810581, 1810582 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60923-284-10 | Exondys 51 | 10 mL in 1 VIAL, SINGLE-USE | INJECTION | 10 | | 15 |
| 60923-284-10 | Exondys 51 | 1 in 1 CARTON | INJECTION | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60923-284 | EXONDYS 51 (ETEPLIRSEN) INJECTION [SAREPTA THERAPEUTICS, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250112_33bff678-7829-479e-9110-b8e33a0bc0aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60923-284-10 | 60923028410 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) / 10 mL in 1 VIAL, SINGLE-USE | 2016-09-19 | 0000-00-00 | No | No | Current |