isosorbide dinitrate and hydralazine hydrochloride

Generic: hydralazine hydrochloride and isosorbide dinitrate

Labeler: wilshire pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name isosorbide dinitrate and hydralazine hydrochloride
Generic Name hydralazine hydrochloride and isosorbide dinitrate
Labeler wilshire pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 37.5 mg/1, isosorbide dinitrate 20 mg/1

Manufacturer
Wilshire Pharmaceuticals

Identifiers & Regulatory

Product NDC 52536-006
Product ID 52536-006_13386839-9eb4-4956-a788-d94a7b63cb77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020727
Listing Expiration 2026-12-31
Marketing Start 2022-04-15

Pharmacologic Class

Established (EPC)
nitrate vasodilator [epc]
Chemical Structure
nitrates [cs]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52536006
Hyphenated Format 52536-006

Supplemental Identifiers

RxCUI
905377
UPC
0352536006095
UNII
FD171B778Y IA7306519N
NUI
N0000175415 M0014874 N0000009909

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isosorbide dinitrate and hydralazine hydrochloride (source: ndc)
Generic Name hydralazine hydrochloride and isosorbide dinitrate (source: ndc)
Application Number NDA020727 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)
source: ndc

Packages (1)

52536-006-09 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)

Ingredients (2)

hydralazine hydrochloride (37.5 mg/1) isosorbide dinitrate (20 mg/1)

Linked Drug Pages (1)

isosorbide dinitrate and hydralazine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13386839-9eb4-4956-a788-d94a7b63cb77", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0352536006095"], "unii": ["FD171B778Y", "IA7306519N"], "rxcui": ["905377"], "spl_set_id": ["620a0680-aad0-4923-84be-7393c0cbdcbd"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Wilshire Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)", "package_ndc": "52536-006-09", "marketing_start_date": "20220415"}], "brand_name": "isosorbide dinitrate and hydralazine hydrochloride", "product_id": "52536-006_13386839-9eb4-4956-a788-d94a7b63cb77", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]", "Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "52536-006", "generic_name": "hydralazine hydrochloride and isosorbide dinitrate", "labeler_name": "Wilshire Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "isosorbide dinitrate and hydralazine hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "37.5 mg/1"}, {"name": "ISOSORBIDE DINITRATE", "strength": "20 mg/1"}], "application_number": "NDA020727", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220415", "listing_expiration_date": "20261231"}