cefdinir 125 mg/5mL
cefdinir · POWDER, FOR SUSPENSION · A-S Medication Solutions
Cefdinir is an oral antibiotic in the cephalosporin class used to treat bacterial infections such as ear infections, sinus infections, strep throat, and pneumonia. This liquid suspension formulation is taken by mouth and comes in a strength of 125 mg per 5 mL.
Key Facts
- Brand Name
- cefdinir
- Generic Name
- cefdinir
- NDC Code (Product)
50090-7929- Manufacturer
- A-S Medication Solutions
- Strength
- 125 mg/5mL
- Dosage Form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210534
- Drug Class
- Cephalosporin Antibacterial [EPC]
- Marketing Start
- 02/20/2021
Recall History
Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Lupin Pharmaceuticals Inc.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc.
Superpotent Drug
Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Lupin Pharmaceuticals Inc.
Defective container: lack of seal integrity.
Lupin Pharmaceuticals Inc.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.
Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.
Teva Pharmaceuticals USA, Inc.
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Lupin Pharmaceuticals Inc.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is cefdinir used for?
Cefdinir is an oral antibiotic in the cephalosporin class used to treat bacterial infections such as ear infections, sinus infections, strep throat, and pneumonia. This liquid suspension formulation is taken by mouth and comes in a strength of 125 mg per 5 mL.
Is cefdinir a controlled substance?
cefdinir is not classified as a controlled substance by the DEA.
What is the generic name for cefdinir?
The generic name for cefdinir is cefdinir. There are 12 other brand versions of cefdinir.
What is the NDC code for cefdinir 125 mg/5mL?
The NDC (National Drug Code) for cefdinir 125 mg/5mL is 50090-7929, listed by A-S Medication Solutions.