NDC 68180-722 – Cefdinir
Cefdinir 125 mg/5mL · Powder, For Suspension · Oral
Product NDC68180-722
Product details
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Labeler
- Lupin Pharmaceuticals, Inc.
- Dosage form
- Powder, For Suspension
- Route
- Oral
- Marketing category
- ANDA · ANDA065259
- Marketed since
- May 31, 2006
- Listing expires
- December 31, 2026
- Pharmacologic class
- Cephalosporin Antibacterial
Active ingredients
- Cefdinir 125 mg/5mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 68180-722-04 | 60 mL in 1 BOTTLE (68180-722-04) | May 22, 2020 |
| 68180-722-05 | 100 mL in 1 BOTTLE (68180-722-05) | May 22, 2020 |
Recalls mentioning this NDC
- D-0518-2024 Jun 5, 2024 · Class II
Defective container: lack of seal integrity. - D-0497-2024 May 22, 2024 · Class II
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. - D-0496-2024 May 22, 2024 · Class II
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. - D-1406-2020 Jul 29, 2020 · Class II
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. - D-0306-2020 Nov 13, 2019 · Class III
Presence of Foreign substance: identified as a dead ant. - D-0305-2020 Nov 13, 2019 · Class III
Presence of Foreign substance: identified as a dead ant. - D-1320-2019 Jun 5, 2019 · Class II
Complaint received of metal piece identified in the product bottle prior to the reconstitution. - D-0375-2019 Jan 16, 2019 · Class II
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. - D-0376-2019 Jan 16, 2019 · Class II
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. - D-0684-2018 Apr 25, 2018 · Class II
Superpotent Drug
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