NDC 67877-544 – Cephalexin
Cephalexin 125 mg/5mL · For Suspension · Oral
Product NDC67877-544
Product details
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Labeler
- Ascend Laboratories, LLC
- Dosage form
- For Suspension
- Route
- Oral
- Marketing category
- ANDA · ANDA210221
- Marketed since
- March 28, 2019
- Listing expires
- December 31, 2026
- Pharmacologic class
- Cephalosporin Antibacterial
Active ingredients
- Cephalexin 125 mg/5mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 67877-544-68 | 200 mL in 1 BOTTLE (67877-544-68) | Mar 28, 2019 |
| 67877-544-88 | 100 mL in 1 BOTTLE (67877-544-88) | Mar 28, 2019 |
Recalls mentioning this NDC
- D-0468-2025 Jun 18, 2025 · Class II
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was… - D-0469-2025 Jun 18, 2025 · Class II
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was… - D-0264-2021 Feb 24, 2021 · Class II
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. - D-0263-2021 Feb 24, 2021 · Class II
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. - D-0185-2021 Jan 13, 2021 · Class II
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL. - D-0178-2021 Jan 6, 2021 · Class II
Failed Impurity/Degradation Specifications - D-0179-2021 Jan 6, 2021 · Class II
Failed Impurity/Degradation Specifications
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