| NDC Code | 65219-635-01 |
|---|
| Package Description | 2 TRAY in 1 CARTON (65219-635-01) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65219-635-00) / 1 mL in 1 VIAL, SINGLE-DOSE |
|---|
| Product NDC | 65219-635 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Phytonadione |
|---|
| Non-Proprietary Name | Phytonadione |
|---|
| Dosage Form | INJECTION, EMULSION |
|---|
| Usage | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
|---|
| Start Marketing Date | 20250510 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA219212 |
|---|
| Manufacturer | Fresenius Kabi USA, LLC |
|---|
| Substance Name | PHYTONADIONE |
|---|
| Strength | 10 |
|---|
| Strength Unit | mg/mL |
|---|
| Pharmacy Classes | Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC] |
|---|