Prescription drug · ANDA
Cefpodoxime Proxetil NDC 67877-878
Cefpodoxime proxetil 100 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-878-01 | 67877087801 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-878-01)Marketed from Mar 1, 2023 | |
| 67877-878-05 | 67877087805 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-878-05)Marketed from Mar 1, 2023 | |
| 67877-878-20 | 67877087820 | 20 TABLET, FILM COATED in 1 BOTTLE (67877-878-20)Marketed from Mar 1, 2023 |
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)
- Cefpodoxime Proxetil
- Generic name (nonproprietary)
- cefpodoxime proxetil
- Active ingredients
- Cefpodoxime proxetil — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210568
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 67877-878_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bdSPL ID 1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bdSPL set ID ce5646cb-a450-4c2c-8499-6ecf71b12b0eRxCUI 309076, 309078UNII 2TB00A1Z7NUPC 0367877878201, 0367877879208
- 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
N467877087801followed by a unit qualifier and the quantityPackage 67877-0878-01. 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)
INDICATIONS AND USAGE Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute otitis media caused by Streptococcus pneumoniae (excluding penicillin-resistant strains), Streptococcus pyogenes, Haemophilusinfluenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused b…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210568
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 |
|---|---|---|---|---|
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-879 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-083 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3616 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-084 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-559 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-560 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3441 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Amici Pharmaceuticals, LLC. | 69292-514 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Amici Pharmaceuticals, LLC. | 69292-516 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2332 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2331 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4676 |