Cefuroxime Axetil
- Product NDC
- 67046-1081
- 11-digit product format
- 670461081
- Labeler code
- 67046
- Product ID
- 67046-1081_2c3a51b0-6e4a-9ae0-e063-6394a90acc40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime Axetil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA065308
- Marketing category
- ANDA
- Marketing start
- 2025-01-21
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1081-3 | 67046108103 | 30 TABLET in 1 BLISTER PACK (67046-1081-3) | 30 tablet | 2025-01-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cefuroxime Axetil | Coupler LLC | 2025-01-21 | HUMAN PRESCRIPTION DRUG LABEL | 1 |