Cefuroxime axetil
- Product NDC
- 21695-370
- 11-digit product format
- 216950370
- Labeler code
- 21695
- Product ID
- 21695-370_1f35ed70-4947-4d4d-b4c8-71ce520fc445
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime axetil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA065308
- Marketing category
- ANDA
- Marketing start
- 2006-03-29
- Marketing end
- 0000-00-00
- Substance
- CEFUROXIME AXETIL
- Active strength
- 250 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba66f2a7-7ba5-e81a-8863-a38bd5c2e969 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-370-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4afd-48b1-e053-8cdaa90a720a | Cefuroxime axetil |
| 21695-370-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4afd-48b1-e053-8cdaa90a720a | Cefuroxime axetil |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-370-10 | Cefuroxime axetil | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 21695-370-20 | Cefuroxime axetil | 20 in 1 BOTTLE | TABLET | 20 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-370-10 | EA - Each | 21695-370 | f245955c-d112-486f-ae14-9f18979b9e1c | 1 | 2012-07-24 |
| 21695-370-20 | EA - Each | 21695-370 | e864bfa0-93c4-49c1-bbfd-c882d3dfdb50 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Cefuroxime Axetil | ACTIVE INGREDIENT | Z49QDT0J8Z | CEFUROXIME AXETIL TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Cefuroxime | ACTIVE MOIETY | O1R9FJ93ED | CEFUROXIME AXETIL TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CEFUROXIME AXETIL TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CEFUROXIME AXETIL TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEFUROXIME AXETIL TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | CEFUROXIME AXETIL TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309097 | cefuroxime axetil 250 MG Oral Tablet | PSN | 1f35ed70-4947-4d4d-b4c8-71ce520fc445 | 1 |
| 309098 | cefuroxime axetil 500 MG Oral Tablet | PSN | 1f35ed70-4947-4d4d-b4c8-71ce520fc445 | 1 |
| 309097 | cefuroxime 250 MG Oral Tablet | SCD | 1f35ed70-4947-4d4d-b4c8-71ce520fc445 | 1 |
| 309098 | cefuroxime 500 MG Oral Tablet | SCD | 1f35ed70-4947-4d4d-b4c8-71ce520fc445 | 1 |
| 309097 | cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet | SY | 1f35ed70-4947-4d4d-b4c8-71ce520fc445 | 1 |
| 309098 | cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet | SY | 1f35ed70-4947-4d4d-b4c8-71ce520fc445 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-370-10 | 21695037010 | 10 in 1 BOTTLE | Historical |
| 21695-370-20 | 21695037020 | 20 in 1 BOTTLE | Historical |