NDC 24338-010

BiDil

Hydralazine Hydrochloride And Isosorbide Dinitrate

BiDil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Arbor Pharmaceuticals, Inc.. The primary component is Hydralazine Hydrochloride; Isosorbide Dinitrate.

• Product ID: 24338-010_29edf04a-6941-4d02-abd7-6da110bd585a
• NDC: 24338-010
• Product Type: Human Prescription Drug
• Proprietary Name: BiDil
• Generic Name: Hydralazine Hydrochloride And Isosorbide Dinitrate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-05
• Marketing Category: NDA / NDA
• Application Number: NDA020727
• Labeler Name: Arbor Pharmaceuticals, Inc.
• Substance Name: HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
• Active Ingredient Strength: 38 mg/1; mg/1
• Pharm Classes: Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 24338-010-09

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

• Marketing Start Date: 2020-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 24338-010-12 [24338001012]

BiDil TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020727
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-05

NDC 24338-010-18 [24338001018]

BiDil TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020727
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-05

Drug Details

Active Ingredients

Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	37.5 mg/1

OpenFDA Data

• SPL SET ID: e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00
• Manufacturer:
  • Arbor Pharmaceuticals, Inc.
• UNII:
  • IA7306519N
  • FD171B778Y
• RxNorm Concept Unique ID - RxCUI:
  • 905379
  • 905377
• UPC Code:
  • 0324338010181

Pharmacological Class

• Arteriolar Vasodilation [PE]
• Arteriolar Vasodilator [EPC]
• Nitrate Vasodilator [EPC]
• Nitrates [CS]
• Vasodilation [PE]
• Arteriolar Vasodilation [PE]
• Arteriolar Vasodilator [EPC]
• Nitrate Vasodilator [EPC]
• Nitrates [CS]
• Vasodilation [PE]

Medicade Reported Pricing

24338010620 ERYTHROCIN 250 MG FILMTAB

Pricing Unit: EA | Drug Type:

24338010413 ERYTHROMYCIN 500 MG FILMTAB

Pricing Unit: EA | Drug Type:

24338010403 ERYTHROMYCIN 500 MG FILMTAB

Pricing Unit: EA | Drug Type:

24338010213 ERYTHROMYCIN 250 MG FILMTAB

Pricing Unit: EA | Drug Type:

24338010203 ERYTHROMYCIN 250 MG FILMTAB

Pricing Unit: EA | Drug Type:

24338010013 E.E.S. 400 FILMTAB

Pricing Unit: EA | Drug Type:

24338001018 BIDIL TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "BiDil" or generic name "Hydralazine Hydrochloride And Isosorbide Dinitrate"

NDC	Brand Name	Generic Name
24338-010	BiDil	Hydralazine hydrochloride and Isosorbide dinitrate
52536-006	isosorbide dinitrate and hydralazine hydrochloride	hydralazine hydrochloride and isosorbide dinitrate