NDC 0378-5186 – Prasugrel
Prasugrel Hydrochloride 10 mg/1 · Tablet, Film Coated · Oral
Product NDC0378-5186
Product details
- Brand name
- Prasugrel
- Generic name
- Prasugrel
- Labeler
- Mylan Pharmaceuticals Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA205927
- Marketed since
- August 15, 2017
- Listing expires
- December 31, 2026
- Pharmacologic class
- P2Y12 Platelet Inhibitor
Active ingredients
- Prasugrel Hydrochloride 10 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0378-5186-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93) | Aug 15, 2017 |
Recalls mentioning this NDC
- D-0839-2026 Sep 9, 2026 · Class II
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria - D-0280-2025 Mar 26, 2025 · Class II
Failed Dissolution Specifications - low dissolution results - D-0155-2020 Nov 6, 2019 · Class II
Failed Dissolution Specification: Low out of specification dissolution results.
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