Cefuroxime axetil
- Product NDC
- 80425-0571
- 11-digit product format
- 804250571
- Labeler code
- 80425
- Product ID
- 80425-0571_48d96610-0a63-48c4-e063-6294a90a0388
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime axetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA065496
- Marketing category
- ANDA
- Marketing start
- 2026-01-16
- Substance
- CEFUROXIME AXETIL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefuroxime axetil
- Listing expiration
- 2027-12-31
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 |
|---|
| 80425-0571-1 | Cefuroxime axetil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 80425-0571-2 | Cefuroxime axetil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0571-1 | 80425057101 | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0571-1) | 2026-01-16 | No | No | Historical |
| 80425-0571-2 | 80425057102 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0571-2) | 2026-01-16 | No | No | Historical |