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NDC 39822-0500-04 Hydralazine Hydrochloride 20 mg/mL Details
Hydralazine Hydrochloride 20 mg/mL
Hydralazine Hydrochloride is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is HYDRALAZINE HYDROCHLORIDE.
Product Information
| NDC | 39822-0500 |
|---|---|
| Product ID | 39822-0500_eedc429c-f1bd-6111-e053-2995a90a70b4 |
| Associated GPIs | 36400010102005 |
| GCN Sequence Number | 000283 |
| GCN Sequence Number Description | hydralazine HCl VIAL 20 MG/ML INJECTION |
| HIC3 | A4A |
| HIC3 Description | ANTIHYPERTENSIVES, VASODILATORS |
| GCN | 01225 |
| HICL Sequence Number | 000089 |
| HICL Sequence Number Description | HYDRALAZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Hydralazine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydralazine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | HYDRALAZINE HYDROCHLORIDE |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203110 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 39822-0500-04 (39822050004)
| NDC Package Code | 39822-0500-4 |
|---|---|
| Billing NDC | 39822050004 |
| Package | 25 VIAL in 1 CARTON (39822-0500-4) / 1 mL in 1 VIAL (39822-0500-1) |
| Marketing Start Date | 2015-06-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |