NDC 43547-368 – Valsartan
Valsartan 80 mg/1 · Tablet · Oral
Product NDC43547-368
Product details
- Brand name
- Valsartan
- Generic name
- Valsartan
- Labeler
- Solco Healthcare US, LLC
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA204821
- Marketed since
- August 31, 2015
- Listing expires
- December 31, 2027
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
Active ingredients
- Valsartan 80 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 43547-368-03 | 30 TABLET in 1 BOTTLE (43547-368-03) | Aug 31, 2015 |
| 43547-368-09 | 90 TABLET in 1 BOTTLE (43547-368-09) | Aug 31, 2015 |
| 43547-368-11 | 1000 TABLET in 1 BOTTLE (43547-368-11) | Aug 31, 2015 |
| 43547-368-50 | 500 TABLET in 1 BOTTLE (43547-368-50) | Aug 31, 2015 |
Recalls mentioning this NDC
- D-0971-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0969-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0970-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0968-2018 Aug 1, 2018 · Class II
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-0209-2018 Jan 17, 2018 · Class II
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Other Valsartan products
- 50090-5191 Valsartan 160 mg/1 · Tablet · A-S Medication Solutions
- 50090-5190 Valsartan 80 mg/1 · Tablet · A-S Medication Solutions
- 50090-7312 Valsartan 320 mg/1 · Tablet · A-S Medication Solutions
- 50090-5192 Valsartan 320 mg/1 · Tablet · A-S Medication Solutions
- 50090-2424 Valsartan 80 mg/1 · Tablet · A-S Medication Solutions
- 62332-047 Valsartan 320 mg/1 · Tablet · Alembic Pharmaceuticals Inc.
- 62332-044 Valsartan 40 mg/1 · Tablet · Alembic Pharmaceuticals Inc.
- 62332-046 Valsartan 160 mg/1 · Tablet · Alembic Pharmaceuticals Inc.
- 62332-045 Valsartan 80 mg/1 · Tablet · Alembic Pharmaceuticals Inc.
- 46708-046 Valsartan 160 mg/1 · Tablet · Alembic Pharmaceuticals Limited
- 46708-045 Valsartan 80 mg/1 · Tablet · Alembic Pharmaceuticals Limited
- 46708-047 Valsartan 320 mg/1 · Tablet · Alembic Pharmaceuticals Limited