Prescription drug · ANDA
Cefuroxime axetil NDC 63187-991
Cefuroxime axetil 250 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-991-20 | 63187099120 | 20 TABLET, FILM COATED in 1 BOTTLE (63187-991-20)Marketed from Mar 1, 2018 | |
| 63187-991-60 | 63187099160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-991-60)Marketed from Dec 1, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065496
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 63187-991_8251b1f4-6da1-461e-9512-fed77a1f402bSPL ID 8251b1f4-6da1-461e-9512-fed77a1f402bSPL set ID e9a020ec-e446-469a-b1d1-07e82eefa305RxCUI 309097UNII Z49QDT0J8ZUPC 0363187991203
- 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
N463187099120followed by a unit qualifier and the quantityPackage 63187-0991-20. 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 tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: • 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065496
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 250 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-215 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-216 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1637 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2168 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-035 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2159 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2157 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2158 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0571 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-333 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-334 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7542 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3975 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-272 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-283 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-656 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-657 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4947 |