NDC 43547-312 – Valsartan And Hydrochlorothiazide
Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film Coated · Oral
Product NDC43547-312
Product details
- Brand name
- Valsartan And Hydrochlorothiazide
- Generic name
- Valsartan and hydrochlorothiazide
- Labeler
- Solco Healthcare US, LLC
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA206083
- Marketed since
- October 31, 2015
- Listing expires
- December 31, 2027
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
Active ingredients
- Valsartan 160 mg/1
- Hydrochlorothiazide 12.5 mg/1
Uses, dosage, side effects and warnings for Valsartan and Hydrochlorothiazide →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 43547-312-03 | 30 TABLET, FILM COATED in 1 BOTTLE (43547-312-03) | Dec 3, 2021 |
| 43547-312-09 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-312-09) | Dec 3, 2021 |
| 43547-312-50 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-312-50) | Dec 3, 2021 |
Recalls mentioning this NDC
- D-0975-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0976-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0973-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0974-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0972-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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