Cefuroxime axetil
- Product NDC
- 0904-7542
- 11-digit product format
- 009047542
- Labeler code
- 0904
- Product ID
- 0904-7542_8f3e739a-07d6-48a6-812f-49e049048bd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime axetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA065496
- Marketing category
- ANDA
- Marketing start
- 2025-08-25
- Substance
- CEFUROXIME AXETIL
- Active strength
- 250 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z49QDT0J8Z |
| Rxcui | 309097 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7542-10 | Cefuroxime axetil | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 3 |
| 0904-7542-10 | Cefuroxime axetil | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7542-10 | 00904754210 | 2 BLISTER PACK in 1 CARTON (0904-7542-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2025-08-25 | No | No | Historical |