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NDC 50742-0246-18 Isosorbide dinitrate and hydralazine hydrochloride 37.5; 20 mg/1; mg/1 Details
Isosorbide dinitrate and hydralazine hydrochloride 37.5; 20 mg/1; mg/1
Isosorbide dinitrate and hydralazine hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ingenus Pharmaceuticals, LLC. The primary component is HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE.
MedlinePlus Drug Summary
Hydralazine is used to treat high blood pressure. Hydralazine is in a class of medications called vasodilators. It works by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 50742-0246-18Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydralazine
Product Information
| NDC | 50742-0246 |
|---|---|
| Product ID | 50742-246_62228a4b-3e48-471c-9e51-37bf1f44cb7b |
| Associated GPIs | 40995002400320 |
| GCN Sequence Number | 059324 |
| GCN Sequence Number Description | isosorbide dinit/hydralazine TABLET 20-37.5MG ORAL |
| HIC3 | A7J |
| HIC3 Description | VASODILATORS, COMBINATION |
| GCN | 24925 |
| HICL Sequence Number | 033009 |
| HICL Sequence Number Description | ISOSORBIDE DINITRATE/HYDRALAZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Isosorbide dinitrate and hydralazine hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Isosorbide dinitrate and hydralazine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 37.5; 20 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
| Labeler Name | Ingenus Pharmaceuticals, LLC |
| Pharmaceutical Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215586 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50742-0246-18 (50742024618)
| NDC Package Code | 50742-246-18 |
|---|---|
| Billing NDC | 50742024618 |
| Package | 180 TABLET in 1 BOTTLE (50742-246-18) |
| Marketing Start Date | 2022-02-12 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.57638 |
| Pricing Unit | EA |
| Effective Date | 2022-11-16 |
| NDC Description | ISOSORBIDE-HYDRALAZINE 20-37.5 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |