NDC 55111-682 – Ibu
Ibuprofen 400 mg/1 · Tablet · Oral
Product NDC55111-682
Product details
- Brand name
- Ibu
- Generic name
- Ibuprofen
- Labeler
- Dr. Reddy's Laboratories Limited
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA075682
- Marketed since
- November 20, 2008
- Listing expires
- December 31, 2026
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Active ingredients
- Ibuprofen 400 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 55111-682-01 | 100 TABLET in 1 BOTTLE (55111-682-01) | Nov 20, 2008 |
| 55111-682-05 | 500 TABLET in 1 BOTTLE (55111-682-05) | Nov 20, 2008 |
| 55111-682-09 | 90 TABLET in 1 BOTTLE (55111-682-09) | Nov 20, 2008 |
Recalls mentioning this NDC
- D-0047-2025 Nov 27, 2024 · Class III
Failed Tablet/Capsule Specifications - D-0646-2024 Sep 4, 2024 · Class II
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. - D-0644-2024 Sep 4, 2024 · Class II
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. - D-0645-2024 Sep 4, 2024 · Class II
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. - D-1042-2013 Sep 25, 2013 · Class II
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
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- 71610-550 Ibuprofen 800 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC
- 55111-683 Ibuprofen 600 mg/1 · Tablet · Dr. Reddy's Laboratories Limited
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