NDC 0378-1723 – Amlodipine And Valsartan
Amlodipine Besylate 5 mg/1; Valsartan 320 mg/1 · Tablet, Film Coated · Oral
Product NDC0378-1723
Product details
- Brand name
- Amlodipine And Valsartan
- Generic name
- Amlodipine And Valsartan
- Labeler
- Mylan Pharmaceuticals Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA090483
- Marketed since
- March 30, 2015
- Listing expires
- December 31, 2026
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker
Active ingredients
- Amlodipine Besylate 5 mg/1
- Valsartan 320 mg/1
Uses, dosage, side effects and warnings for Amlodipine And Valsartan →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0378-1723-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1723-93) | Mar 30, 2015 |
Recalls mentioning this NDC
- D-0321-2019 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-0312-2019 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-0322-2019 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-0318-2019 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-0320-2019 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-0323-2019 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-0311-2019 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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