NDC 0378-5814 – Valsartan
Valsartan 160 mg/1 · Tablet, Film Coated · Oral
Product NDC0378-5814
Product details
- Brand name
- Valsartan
- Generic name
- Valsartan
- Labeler
- Mylan Pharmaceuticals Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA090866
- Marketed since
- January 5, 2015
- Listing expires
- December 31, 2027
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
Active ingredients
- Valsartan 160 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0378-5814-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5814-77) | Jan 5, 2015 |
Recalls mentioning this NDC
- D-0316-2019 Dec 19, 2018 · Class II
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-0315-2019 Dec 19, 2018 · Class II
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-0313-2019 Dec 19, 2018 · Class II
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-0326-2019 Dec 19, 2018 · Class II
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0327-2019 Dec 19, 2018 · Class II
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0314-2019 Dec 19, 2018 · Class II
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-0324-2019 Dec 19, 2018 · Class II
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0325-2019 Dec 19, 2018 · Class II
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
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