Vyondys 53
- Product NDC
- 60923-465
- 11-digit product format
- 609230465
- Labeler code
- 60923
- Product ID
- 60923-465_5fbaac76-f7cb-4f43-99f8-af43c2655ff0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- golodirsen
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sarepta Therapeutics, Inc.
- Application
- NDA211970
- Marketing category
- NDA
- Marketing start
- 2019-12-12
- Substance
- GOLODIRSEN
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Antisense Oligonucleotide [EPC], Increased Protein Synthesis [PE], 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
- Vyondys 53
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GOLODIRSEN | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 033072U4MZ |
| Rxcui | 2267211, 2267216 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60923-465-02 | Vyondys 53 | 2 mL in 1 VIAL, SINGLE-USE | INJECTION | 2 | | 16 |
| 60923-465-02 | Vyondys 53 | 1 in 1 CARTON | INJECTION | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60923-465 | VYONDYS 53 (GOLODIRSEN) INJECTION [SAREPTA THERAPEUTICS, INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20250321_35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5.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 |
|---|
| 60923-465-02 | 60923046502 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-465-02) / 2 mL in 1 VIAL, SINGLE-USE | 2019-12-12 | 0000-00-00 | No | No | Current |