bidil

Generic: hydralazine hydrochloride and isosorbide dinitrate

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24338-010
Product ID 24338-010_79524516-67d7-45ef-bf97-878c6dc8d6ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020727
Listing Expiration 2027-12-31
Marketing Start 2012-12-05

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 24338010
Hyphenated Format 24338-010

Supplemental Identifiers

RxCUI
905377 905379
UPC
0324338010099
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 bidil (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 (24338-010-09)
source: ndc

Packages (1)

24338-010-09 90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09)

Ingredients (2)

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

Linked Drug Pages (1)

BiDil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79524516-67d7-45ef-bf97-878c6dc8d6ef", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0324338010099"], "unii": ["FD171B778Y", "IA7306519N"], "rxcui": ["905377", "905379"], "spl_set_id": ["e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09)", "package_ndc": "24338-010-09", "marketing_start_date": "20200831"}], "brand_name": "BiDil", "product_id": "24338-010_79524516-67d7-45ef-bf97-878c6dc8d6ef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]", "Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "24338-010", "generic_name": "Hydralazine hydrochloride and Isosorbide dinitrate", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BiDil", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "37.5 mg/1"}, {"name": "ISOSORBIDE DINITRATE", "strength": "20 mg/1"}], "application_number": "NDA020727", "marketing_category": "NDA", "marketing_start_date": "20121205", "listing_expiration_date": "20271231"}