NDC Code | 0121-0976-10 |
Package Description | 10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55) |
Product NDC | 0121-0976 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Cefotan |
Non-Proprietary Name | Cefotetan |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Usage | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20240408 |
Marketing Category Name | NDA |
Application Number | NDA050588 |
Manufacturer | PAI Holdings, LLC dba PAI Pharma |
Substance Name | CEFOTETAN DISODIUM |
Strength | 1 |
Strength Unit | g/10mL |
Pharmacy Classes | Cephalosporin Antibacterial [EPC], Cephalosporins [CS] |