Cefuroxime Axetil
- Product NDC
- 68788-8905
- 11-digit product format
- 687888905
- Labeler code
- 68788
- Product ID
- 68788-8905_bc9200d2-4a6d-4847-ba85-8e9d378390de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime Axetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA065308
- Marketing category
- ANDA
- Marketing start
- 2025-07-31
- Substance
- CEFUROXIME AXETIL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Z49QDT0J8Z | CEFUROXIME AXETIL | 64544-07-6 | CEFUROXIME AXETIL |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8905-2 | 68788890502 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8905-2) | 2025-07-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cefuroxime Axetil | Preferred Pharmaceuticals Inc. | 2025-07-31 | HUMAN PRESCRIPTION DRUG LABEL | 1 |