NDC 0378-6325 – Valsartan and Hydrochlorothiazide
Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet, Film Coated · Oral
Product NDC0378-6325
Product details
- Brand name
- Valsartan and Hydrochlorothiazide
- Generic name
- valsartan and hydrochlorothiazide
- Labeler
- Mylan Pharmaceuticals Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA078020
- Marketed since
- September 21, 2012
- Listing expires
- December 31, 2026
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
Active ingredients
- Valsartan 320 mg/1
- Hydrochlorothiazide 25 mg/1
Uses, dosage, side effects and warnings for Valsartan and Hydrochlorothiazide →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0378-6325-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6325-77) | Sep 21, 2012 |
Recalls mentioning this NDC
- D-0329-2019 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-0331-2019 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-0332-2019 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-0328-2019 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-0330-2019 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-0317-2019 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.
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