Prasugrel
- Product NDC
- 29300-302
- 11-digit product format
- 293000302
- Labeler code
- 29300
- Product ID
- 29300-302_b60d626b-a3ab-45a0-9abc-cce73f2039da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prasugrel
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA213315
- Marketing category
- ANDA
- Marketing start
- 2023-10-16
- 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, 855818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-302-13 | Prasugrel | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-302 | PRASUGREL TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | Current NDC, 1 package rows | 20231016_5edc1ab3-5c7a-47d6-8aaa-00523c9b4c8f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 29300-302-13 | 29300030213 | 30 TABLET, FILM COATED in 1 BOTTLE (29300-302-13) | 2023-10-16 | No | No | Current |