Prasugrel
- Product NDC
- 63629-4829
- 11-digit product format
- 636294829
- Labeler code
- 63629
- Product ID
- 63629-4829_9221d9d1-600c-4a0b-8234-bff051dfb4da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prasugrel
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205888
- Marketing category
- ANDA
- Marketing start
- 2017-10-16
- Substance
- PRASUGREL HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prasugrel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRASUGREL HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G89JQ59I13 |
| Rxcui | 855812 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-4829-1 | Prasugrel | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 63629-4829-2 | Prasugrel | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-4829 | PRASUGREL TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1 | Current NDC, 2 package rows | 20241127_9c3994da-da45-43ce-9727-a842a43c5693.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-4829-1 | 63629482901 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-4829-1) | 2024-11-25 | No | No | Historical |
| 63629-4829-2 | 63629482902 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-4829-2) | 2024-11-25 | No | No | Historical |