NDC 43547-376 – Irbesartan
Irbesartan 300 mg/1 · Tablet · Oral
Product NDC43547-376
Product details
- Brand name
- Irbesartan
- Generic name
- Irbesartan
- Labeler
- Solco Healthcare U.S., LLC
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA203071
- Marketed since
- June 13, 2016
- Listing expires
- December 31, 2026
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
Active ingredients
- Irbesartan 300 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 43547-376-03 | 30 TABLET in 1 BOTTLE (43547-376-03) | Jun 13, 2016 |
| 43547-376-09 | 90 TABLET in 1 BOTTLE (43547-376-09) | Jun 13, 2016 |
| 43547-376-50 | 500 TABLET in 1 BOTTLE (43547-376-50) | Jun 13, 2016 |
Recalls mentioning this NDC
- D-0409-2019 Feb 6, 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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