NDC 43547-331 – Irbesartan and Hydrochlorothiazide
Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral
Product NDC43547-331
Product details
- Brand name
- Irbesartan and Hydrochlorothiazide
- Generic name
- Irbesartan and Hydrochlorothiazide
- Labeler
- Solco Healthcare US, LLC
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA203072
- Marketed since
- March 1, 2014
- Listing expires
- December 31, 2027
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
Active ingredients
- Irbesartan 300 mg/1
- Hydrochlorothiazide 12.5 mg/1
Uses, dosage, side effects and warnings for Irbesartan and Hydrochlorothiazide →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 43547-331-03 | 30 TABLET in 1 BOTTLE (43547-331-03) | Mar 1, 2014 |
| 43547-331-09 | 90 TABLET in 1 BOTTLE (43547-331-09) | Mar 1, 2014 |
| 43547-331-50 | 500 TABLET in 1 BOTTLE (43547-331-50) | Mar 1, 2014 |
Recalls mentioning this NDC
- D-0413-2019 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… - D-0410-2019 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… - D-0411-2019 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… - D-0412-2019 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… - D-1049-2016 Jun 29, 2016 · Class III
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
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