Prescription drug · ANDA
Cefuroxime Axetil NDC 67046-1307
Cefuroxime axetil 250 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1307-3 | 67046130703 | 30 TABLET in 1 BLISTER PACK (67046-1307-3)Marketed from Jan 23, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cefuroxime Axetil
- Generic name (nonproprietary)
- cefuroxime axetil
- Active ingredients
- Cefuroxime axetil — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065308
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 67046-1307_2c6191df-9524-9c51-e063-6294a90a236cSPL ID 2c6191df-9524-9c51-e063-6294a90a236cSPL set ID 2c619a79-6b69-b9fa-e063-6394a90a8f27RxCUI 309097UNII Z49QDT0J8Z
- Pharmacologic class
- Cephalosporin Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467046130703followed by a unit qualifier and the quantityPackage 67046-1307-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: ( 1 ) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4 ) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5 ) Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6 ) Uncomplicated gonorrhea (adul…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065308
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2079 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-699 |
| Cefuroxime Axetil | Cefuroxime axetil 125 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-698 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-700 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-7667 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7668 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3899 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3215 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-0781 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-7095 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-0782 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8905 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-058 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-059 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2265 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-623 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | TabletOral | NorthStar Rx LLC | 16714-401 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | NorthStar Rx LLC | 16714-400 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | TabletOral | Coupler LLC | 67046-1081 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-4153 |
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