NDC 65862-571 – Valsartan
Valsartan 80 mg/1 · Tablet, Film Coated · Oral
Product NDC65862-571
Product details
- Brand name
- Valsartan
- Generic name
- Valsartan
- Labeler
- Aurobindo Pharma Limited
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA202223
- Marketed since
- January 5, 2015
- Listing expires
- December 31, 2026
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
Active ingredients
- Valsartan 80 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 65862-571-10 | 10 BLISTER PACK in 1 CARTON (65862-571-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | Jan 5, 2015 |
| 65862-571-90 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-571-90) | Jan 5, 2015 |
| 65862-571-99 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-571-99) | Jan 5, 2015 |
Recalls mentioning this NDC
- D-1038-2019 Mar 27, 2019 · 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-1037-2019 Mar 27, 2019 · 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-1035-2019 Mar 27, 2019 · 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-1039-2019 Mar 27, 2019 · 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-0370-2019 Jan 23, 2019 · Class II
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083…
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