| Product NDC: | 54868-6266 |
| Proprietary Name: | Hydralazine Hydrochloride |
| Non Proprietary Name: | hydralazine hydrochloride |
| Active Ingredient(s): | 20 mg/mL & nbsp; hydralazine hydrochloride |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-6266 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040730 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110517 |
| Package NDC: | 54868-6266-0 |
| Package Description: | 10 VIAL, SINGLE-DOSE in 1 BOX (54868-6266-0) > 1 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 54868-6266-0 |
| Proprietary Name | Hydralazine Hydrochloride |
| Package Description | 10 VIAL, SINGLE-DOSE in 1 BOX (54868-6266-0) > 1 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 54868-6266 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | hydralazine hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20110517 |
| Marketing Category Name | ANDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | HYDRALAZINE HYDROCHLORIDE |
| Strength Number | 20 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] |