NDC 65862-738 – Amlodipine and valsartan
Amlodipine Besylate 5 mg/1; Valsartan 320 mg/1 · Tablet, Film Coated · Oral
Product NDC65862-738
Product details
- Brand name
- Amlodipine and valsartan
- Generic name
- Amlodipine and valsartan
- Labeler
- Aurobindo Pharma Limited
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA206512
- Marketed since
- April 22, 2016
- 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 (3)
| Package NDC | Description | Since |
|---|---|---|
| 65862-738-03 | 3 BLISTER PACK in 1 CARTON (65862-738-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-738-10) | Apr 22, 2016 |
| 65862-738-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-738-30) | Apr 22, 2016 |
| 65862-738-90 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-738-90) | Apr 22, 2016 |
Recalls mentioning this NDC
- D-1036-2019 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-0364-2019 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… - D-0362-2019 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… - D-0361-2019 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… - D-0363-2019 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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