NDC 68462-319 – Ranolazine
Ranolazine 500 mg/1 · Tablet, Film Coated, Extended Release · Oral
Product NDC68462-319
Product details
- Brand name
- Ranolazine
- Generic name
- Ranolazine
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Dosage form
- Tablet, Film Coated, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA211082
- Marketed since
- July 5, 2019
- Listing expires
- December 31, 2027
- Pharmacologic class
- Anti-anginal
Active ingredients
- Ranolazine 500 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 68462-319-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-05) | Jul 5, 2019 |
| 68462-319-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-60) | Jul 5, 2019 |
Recalls mentioning this NDC
- D-0335-2025 Apr 16, 2025 · Class II
CGMP Deviations - D-0092-2024 Nov 15, 2023 · Class II
Failed Dissolution Specifications: Out of specification for dissolution.
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