PHYTONADIONE is a Intramuscular; Intravenous; Subcutaneous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc.. The primary component is Phytonadione.
| Product ID | 52584-405_0c5cfa9f-d9ef-4994-a46c-89d15224cca5 |
| NDC | 52584-405 |
| Product Type | Human Prescription Drug |
| Proprietary Name | PHYTONADIONE |
| Generic Name | Phytonadione |
| Dosage Form | Injection, Emulsion |
| Route of Administration | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Marketing Start Date | 2019-08-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207719 |
| Labeler Name | General Injectables & Vaccines, Inc. |
| Substance Name | PHYTONADIONE |
| Active Ingredient Strength | 10 mg/mL |
| Pharm Classes | Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2019-08-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207719 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-08-20 |
| Ingredient | Strength |
|---|---|
| PHYTONADIONE | 10 mg/mL |
| SPL SET ID: | 902eb3ff-4b34-4b2b-9a64-7f206ebfed90 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0404-9935 | PHYTONADIONE | phytonadione |
| 0404-9969 | PHYTONADIONE | phytonadione |
| 0904-6882 | Phytonadione | Phytonadione |
| 16714-973 | Phytonadione | Phytonadione |
| 43598-405 | PHYTONADIONE | PHYTONADIONE |
| 50268-661 | Phytonadione | phytonadione |
| 52565-142 | Phytonadione | phytonadione |
| 52565-143 | Phytonadione | PHYTONADIONE |
| 52584-043 | PHYTONADIONE | phytonadione |
| 52584-046 | PHYTONADIONE | phytonadione |
| 68682-170 | Phytonadione | Phytonadione |
| 69238-1051 | Phytonadione | Phytonadione |
| 70710-1014 | Phytonadione | Phytonadione |
| 70771-1318 | Phytonadione | Phytonadione |
| 76329-1240 | Phytonadione | Phytonadione |
| 52584-240 | Phytonadione | Phytonadione |
| 60687-381 | Phytonadione | Phytonadione |
| 52584-405 | PHYTONADIONE | PHYTONADIONE |
| 52565-092 | AquaMEPHYTON | phytonadione |
| 52565-093 | AquaMEPHYTON | PHYTONADIONE |
| 0187-1704 | Mephyton | phytonadione |
| 21695-168 | MEPHYTON | phytonadione |
| 50090-1753 | Mephyton | phytonadione |
| 0409-9157 | Vitamin K1 | PHYTONADIONE |
| 0409-9158 | Vitamin K1 | PHYTONADIONE |
| 50090-4521 | Vitamin K1 | PHYTONADIONE |
| 50090-4523 | Vitamin K1 | PHYTONADIONE |