Prescription drug · NDA
Cefotan (cefotetan) NDC 0121-0976
Cefotetan disodium 1 g/10mL · Injection, Powder, For solution · Intramuscular, Intravenous · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0976-10 | 00121097610 | 10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55)Marketed from Apr 8, 2024 |
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)
- Cefotan
- Generic name (nonproprietary)
- cefotetan
- Active ingredients
- Cefotetan disodium — 1 g/10mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050588
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0121-0976_7e29cb53-c401-49b0-9b47-209601f7ec55SPL ID 7e29cb53-c401-49b0-9b47-209601f7ec55SPL set ID f1510f5e-d001-44e0-accb-27cf79fd4f9aRxCUI 1722919, 1722921, 1731542, 1743557UNII 0GXP746VXB
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400121097610followed by a unit qualifier and the quantityPackage 00121-0976-10. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN ® and other antibacterial drugs, CEFOTAN ® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment CEFOTAN® (Cefotetan for Injection, USP) is indicated for the therapeutic treatment of the following infections when caused by susceptible str…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050588
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 |
|---|---|---|---|---|
| Cefotancefotetan | Cefotetan disodium 2 g/20mL | Injection, Powder, For solutionIntramuscular, Intravenous | PAI Holdings, LLC dba PAI Pharma | 0121-0977 |