Cefuroxime Axetil
- Product NDC
- 57237-058
- 11-digit product format
- 572370058
- Labeler code
- 57237
- Product ID
- 57237-058_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime Axetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA065308
- Marketing category
- ANDA
- Marketing start
- 2006-03-29
- 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, 309098 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57237-058-20 | Cefuroxime Axetil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 10 |
| 57237-058-60 | Cefuroxime Axetil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEFUROXIME AXETIL | ACTIVE INGREDIENT | Z49QDT0J8Z | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| CEFUROXIME | ACTIVE MOIETY | O1R9FJ93ED | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-058 | CEFUROXIME AXETIL TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240503_66f8d37f-aebc-4435-af80-dfd7b3770088.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57237-058-20 | 57237005820 | 20 TABLET, FILM COATED in 1 BOTTLE (57237-058-20) | 2006-03-29 | 0000-00-00 | No | No | Current |
| 57237-058-60 | 57237005860 | 60 TABLET, FILM COATED in 1 BOTTLE (57237-058-60) | 2006-03-29 | 0000-00-00 | No | No | Current |