AMONDYS 45
- Product NDC
- 60923-227
- 11-digit product format
- 609230227
- Labeler code
- 60923
- Product ID
- 60923-227_f388df1b-13aa-4b95-a7fa-9694dc86981c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- casimersen
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sarepta Therapeutics, Inc.
- Application
- NDA213026
- Marketing category
- NDA
- Marketing start
- 2021-02-25
- Substance
- CASIMERSEN
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Antisense Oligonucleotide [EPC], Increased Protein Synthesis [PE], Oligonucleotides, Antisense [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMONDYS 45
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CASIMERSEN | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X8UHF7SX0R |
| Rxcui | 2480100, 2480105 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60923-227-02 | AMONDYS 45 | 2 mL in 1 VIAL, SINGLE-USE | INJECTION | 2 | | 11 |
| 60923-227-02 | AMONDYS 45 | 1 in 1 CARTON | INJECTION | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60923-227 | AMONDYS 45 (CASIMERSEN) INJECTION [SAREPTA THERAPEUTICS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250321_e9e5fd44-eeda-4580-bba1-a734828bbcc3.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 |
|---|
| 60923-227-02 | 60923022702 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-227-02) / 2 mL in 1 VIAL, SINGLE-USE | 2021-02-25 | 0000-00-00 | No | No | Current |