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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefuroxime Axetil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEFUROXIME AXETIL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z49QDT0J8Z |
| Rxcui | 309098 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8905-2 | Cefuroxime Axetil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |