Cefuroxime Axetil
- Product NDC
- 55648-922
- 11-digit product format
- 556480922
- Labeler code
- 55648
- Product ID
- 55648-922_f4bea44f-32ac-431b-8909-e81bb02e65ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime Axetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wockhardt Limited
- Application
- ANDA065166
- Marketing category
- ANDA
- Marketing start
- 2005-07-29
- Marketing end
- 0000-00-00
- Substance
- CEFUROXIME AXETIL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55648-922-01 | Cefuroxime Axetil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 2 |
| 55648-922-02 | Cefuroxime Axetil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
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 [WOCKHARDT LIMITED] | 1 | |
| CEFUROXIME | ACTIVE MOIETY | O1R9FJ93ED | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| SMCC | INACTIVE INGREDIENT | B357P1G1IF | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55648-922 | CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED] | 2 | Legacy NDC, 2 package rows | 20160105_708b7a4d-ba1f-47b5-be4d-a01c2a7017ff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55648-922-01 | 55648092201 | 20 in 1 BOTTLE | Historical |
| 55648-922-02 | 55648092202 | 60 in 1 BOTTLE | Historical |