Prescription drug · ANDA
Cefpodoxime Proxetil NDC 0781-5438
Cefpodoxime proxetil 100 mg/1 · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-5438-01 | 0078154380100781543801 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5438-01)Marketed from May 28, 2008 | |
| 0781-5438-20 | 0078154382000781543820 | 20 TABLET, FILM COATED in 1 BOTTLE (0781-5438-20)Marketed from May 28, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065462
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0781-5438_5da86042-4c5d-4778-9125-19c942e112e5SPL ID 5da86042-4c5d-4778-9125-19c942e112e5SPL set ID 8519a9d8-7106-4545-bc58-859ee9a6708eRxCUI 309076, 309078UNII 2TB00A1Z7N
- 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
N400781543801followed by a unit qualifier and the quantityPackage 00781-5438-01. 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, Haemophilus influenzae (including beta-lactamase-producing strains), or Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains). Pharyngitis and/or tonsillitis caused …
Excerpt only. Read the full label for complete information.
About NDC 0781-5438
- What is NDC 0781-5438?
- 0781-5438 is the product NDC for Cefpodoxime Proxetil, Cefpodoxime proxetil 100 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefpodoxime Proxetil.
- What is the active ingredient?
- Cefpodoxime proxetil.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefpodoxime Proxetil?
- 26 other product NDCs are listed under this name. See all Cefpodoxime Proxetil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefpodoxime Proxetil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4676 | 70518-4676-00 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2331 | 67296-2331-01 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-878 | 67877-0878-0167877-0878-0567877-0878-20 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3616 | 68071-3616-04 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2332 | 67296-2332-03 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-879 | 67877-0879-0167877-0879-0567877-0879-20 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3441 | 68071-3441-02 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Amici Pharmaceuticals, LLC. | 69292-514 | 69292-0514-0169292-0514-50 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 200 mg/1 | Tablet, Film coatedOral | Amici Pharmaceuticals, LLC. | 69292-516 | 69292-0516-0169292-0516-50 |
| Cefpodoxime Proxetil | Cefpodoxime proxetil 100 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-559 | 67877-0559-0167877-0559-0567877-0559-20 |
Other NDCs under ANDA 065462
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 | Sandoz Inc | 0781-5439 |