Prescription drug · ANDA
Cefotetan (cefotetan disodium) NDC 63323-386
Cefotetan disodium 2 g/20mL · Injection, Powder, For solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-386-20 | 63323038620 | 10 VIAL in 1 CARTON (63323-386-20) / 20 mL in 1 VIAL (63323-386-01)Marketed from Nov 18, 2009 |
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)
- Cefotetan
- Generic name (nonproprietary)
- cefotetan disodium
- Active ingredients
- Cefotetan disodium — 2 g/20mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065374
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 63323-386_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8SPL ID a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8SPL set ID bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800eRxCUI 1722919, 1722921UNII 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
N463323038620followed by a unit qualifier and the quantityPackage 63323-0386-20. 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)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotetan and other antibacterial drugs, cefotetan 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 Cefotetan for Injection, USP is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065374
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 |
|---|---|---|---|---|
| Cefotetancefotetan disodium | Cefotetan disodium 1 g/10mL | Injection, Powder, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-385 |