Cefuroxime Axetil
- Product NDC
- 16714-400
- 11-digit product format
- 167140400
- Labeler code
- 16714
- Product ID
- 16714-400_c89c84c5-710f-4a4a-8171-c38bee355c1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime Axetil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- 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 |
|---|---|
| CEFUROXIME AXETIL | 250 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Z49QDT0J8Z |
| Rxcui | 309097, 309098 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba66f2a7-7ba5-e81a-8863-a38bd5c2e969 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16714-400-01 | Cefuroxime Axetil | 20 in 1 BOTTLE | TABLET | 20 | 12 | |
| 16714-400-02 | Cefuroxime Axetil | 60 in 1 BOTTLE | TABLET | 60 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-400-01 | EA - Each | 16714-400 | 1fc6f6e5-557f-4eeb-bf05-45a972b70b1f | 1 | 2014-09-03 |
| 16714-400-02 | EA - Each | 16714-400 | 83e37bfe-9c89-4b2a-a15a-159082e439b8 | 1 | 2014-09-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CEFUROXIME AXETIL | ACTIVE INGREDIENT | Z49QDT0J8Z | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| CEFUROXIME | ACTIVE MOIETY | O1R9FJ93ED | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC] | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309097 | cefuroxime axetil 250 MG Oral Tablet | PSN | fd79c41e-b0e9-47dc-a3ce-caacdc66bc96 | 12 |
| 309098 | cefuroxime axetil 500 MG Oral Tablet | PSN | fd79c41e-b0e9-47dc-a3ce-caacdc66bc96 | 12 |
| 309097 | cefuroxime 250 MG Oral Tablet | SCD | fd79c41e-b0e9-47dc-a3ce-caacdc66bc96 | 12 |
| 309098 | cefuroxime 500 MG Oral Tablet | SCD | fd79c41e-b0e9-47dc-a3ce-caacdc66bc96 | 12 |
| 309097 | cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet | SY | fd79c41e-b0e9-47dc-a3ce-caacdc66bc96 | 12 |
| 309098 | cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet | SY | fd79c41e-b0e9-47dc-a3ce-caacdc66bc96 | 12 |
| 309097 | cefuroxime axetil 250 MG Oral Tablet | PSN | bcf7870a-7e45-4ae1-a9b4-457e4781886a | 3 |
| 309097 | cefuroxime 250 MG Oral Tablet | SCD | bcf7870a-7e45-4ae1-a9b4-457e4781886a | 3 |
| 309097 | cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet | SY | bcf7870a-7e45-4ae1-a9b4-457e4781886a | 3 |
| 309097 | cefuroxime axetil 250 MG Oral Tablet | PSN | eb180b38-f8c8-4dbf-856a-347d3ebac857 | 1 |
| 309097 | cefuroxime 250 MG Oral Tablet | SCD | eb180b38-f8c8-4dbf-856a-347d3ebac857 | 1 |
| 309097 | cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet | SY | eb180b38-f8c8-4dbf-856a-347d3ebac857 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16714-400-01 | 16714040001 | 20 TABLET in 1 BOTTLE (16714-400-01) | 20 tablet | 2006-03-29 | 0000-00-00 | No | No | Current |
| 16714-400-02 | 16714040002 | 60 TABLET in 1 BOTTLE (16714-400-02) | 60 tablet | 2006-03-29 | 0000-00-00 | No | No | Current |