Prasugrel
- Product NDC
- 16729-273
- 11-digit product format
- 167290273
- Labeler code
- 16729
- Product ID
- 16729-273_0e2f030a-d262-a36c-e063-6294a90a40ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prasugrel
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA205987
- Marketing category
- ANDA
- Marketing start
- 2019-01-16
- 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 |
|---|
| 16729-273-10 | Prasugrel | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-273 | PRASUGREL TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240106_cd6bf899-06b7-4f52-96c5-ffc94a7288ff.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 |
|---|
| 16729-273-10 | 16729027310 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-273-10) | 2019-01-16 | 0000-00-00 | No | No | Current |