Prasugrel
- Product NDC
- 0378-5185
- 11-digit product format
- 003785185
- Labeler code
- 0378
- Product ID
- 0378-5185_9e234352-49b7-46e3-bc59-acf63e0a7a14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prasugrel
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205927
- Marketing category
- ANDA
- Marketing start
- 2017-08-16
- Substance
- PRASUGREL HYDROCHLORIDE
- Active strength
- 5 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 | 5 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 |
|---|
| 0378-5185-93 | Prasugrel | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-5185 | PRASUGREL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240131_41a4e332-6725-4cb7-940a-8291cf56cfe4.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 |
|---|
| 0378-5185-93 | 00378518593 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5185-93) | 2017-08-16 | 0000-00-00 | No | No | Current |