NDC 68462-162 – Carvedilol
Carvedilol 3.125 mg/1 · Tablet, Film Coated · Oral
Product NDC68462-162
Product details
- Brand name
- Carvedilol
- Generic name
- Carvedilol
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA078251
- Marketed since
- September 5, 2007
- Listing expires
- December 31, 2026
- Pharmacologic class
- alpha-Adrenergic Blocker; beta-Adrenergic Blocker
Active ingredients
- Carvedilol 3.125 mg/1
Package NDC codes (5)
| Package NDC | Description | Since |
|---|---|---|
| 68462-162-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-162-01) | Sep 5, 2007 |
| 68462-162-05 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-162-05) | Sep 5, 2007 |
| 68462-162-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-162-10) | Sep 5, 2007 |
| 68462-162-18 | 180 TABLET, FILM COATED in 1 BOTTLE (68462-162-18) | Dec 10, 2014 |
| 68462-162-60 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-162-60) | Sep 5, 2007 |
Recalls mentioning this NDC
- D-0579-2025 Aug 20, 2025 · Class II
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. - D-0577-2025 Aug 20, 2025 · Class II
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. - D-0578-2025 Aug 20, 2025 · Class II
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. - D-0587-2025 Aug 20, 2025 · Class II
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm - D-0588-2025 Aug 20, 2025 · Class II
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm - D-0450-2025 Jun 4, 2025 · Class II
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0449-2025 Jun 4, 2025 · Class II
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0451-2025 Jun 4, 2025 · Class II
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0448-2025 Jun 4, 2025 · Class II
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0336-2025 Apr 16, 2025 · Class II
CGMP Deviations
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