| Product NDC: | 52584-043 |
| Proprietary Name: | PHYTONADIONE |
| Non Proprietary Name: | phytonadione |
| Active Ingredient(s): | 1 mg/.5mL & nbsp; phytonadione |
| Administration Route(s): | PARENTERAL |
| Dosage Form(s): | INJECTION, EMULSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52584-043 |
| Labeler Name: | General Injectables & Vaccines, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA083722 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130213 |
| Package NDC: | 52584-043-05 |
| Package Description: | 1 CARTON in 1 BAG (52584-043-05) > 1 SYRINGE in 1 CARTON > .5 mL in 1 SYRINGE |
| NDC Code | 52584-043-05 |
| Proprietary Name | PHYTONADIONE |
| Package Description | 1 CARTON in 1 BAG (52584-043-05) > 1 SYRINGE in 1 CARTON > .5 mL in 1 SYRINGE |
| Product NDC | 52584-043 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | phytonadione |
| Dosage Form Name | INJECTION, EMULSION |
| Route Name | PARENTERAL |
| Start Marketing Date | 20130213 |
| Marketing Category Name | ANDA |
| Labeler Name | General Injectables & Vaccines, Inc |
| Substance Name | PHYTONADIONE |
| Strength Number | 1 |
| Strength Unit | mg/.5mL |
| Pharmaceutical Classes | Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] |