NDC 33342-046 – Losartan potassium
Losartan Potassium 100 mg/1 · Tablet, Film Coated · Oral
Product NDC33342-046
Product details
- Brand name
- Losartan potassium
- Generic name
- Losartan potassium
- Labeler
- Macleods Pharmaceuticals Limited
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA202230
- Marketed since
- June 1, 2012
- Listing expires
- December 31, 2026
- Pharmacologic class
- Angiotensin 2 Receptor Blocker
Active ingredients
- Losartan Potassium 100 mg/1
Uses, dosage, side effects and warnings for Losartan potassium →
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 33342-046-07 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-046-07) | Jun 1, 2012 |
| 33342-046-10 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-046-10) | Jun 1, 2012 |
| 33342-046-12 | 10 BLISTER PACK in 1 CARTON (33342-046-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | Jun 1, 2012 |
| 33342-046-44 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-046-44) | Jan 18, 2016 |
Recalls mentioning this NDC
- D-0832-2022 May 11, 2022 · Class II
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0834-2022 May 11, 2022 · Class II
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0833-2022 May 11, 2022 · Class II
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-1458-2019 Jul 17, 2019 · Class II
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. - D-1457-2019 Jul 17, 2019 · Class II
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
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