Prescription drug · ANDA
Cefuroxime axetil NDC 43063-657
Cefuroxime axetil 250 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-657-20 | 43063065720 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-657-20)Marketed from Feb 5, 2016 | |
| 43063-657-60 | 43063065760 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-657-60)Marketed from Dec 18, 2019 |
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
- PD-Rx Pharmaceuticals, Inc.
- 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 43063-657_4139efd1-921a-b349-e063-6394a90a0404SPL ID 4139efd1-921a-b349-e063-6394a90a0404SPL set ID 2af94304-8118-41c7-e054-00144ff8d46cRxCUI 309097UNII Z49QDT0J8ZUPC 0343063657201
- 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
N443063065720followed by a unit qualifier and the quantityPackage 43063-0657-20. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-991 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-4947 |