NDC 75834-127

Hydralazine

Hydralazine Hydrochloride

Hydralazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is Hydralazine Hydrochloride.

• Product ID: 75834-127_379fe677-a8e7-4bfe-abcf-85283768c27b
• NDC: 75834-127
• Product Type: Human Prescription Drug
• Proprietary Name: Hydralazine
• Generic Name: Hydralazine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203845
• Labeler Name: Nivagen Pharmaceuticals, Inc.
• Substance Name: HYDRALAZINE HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 75834-127-00

1000 TABLET in 1 BOTTLE (75834-127-00)

• Marketing Start Date: 2017-02-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75834-127-00 [75834012700]

Hydralazine TABLET

• Marketing Category: ANDA
• Application Number: ANDA203845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-15
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-06

NDC 75834-127-01 [75834012701]

Hydralazine TABLET

• Marketing Category: ANDA
• Application Number: ANDA203845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-15
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-06

Drug Details

Active Ingredients

Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	50 mg/1

OpenFDA Data

• SPL SET ID: 1fd8cf42-66ae-4af5-a5ae-7c9679a0e532
• Manufacturer:
  • Nivagen Pharmaceuticals, Inc.
• UNII:
  • FD171B778Y
• RxNorm Concept Unique ID - RxCUI:
  • 905225
  • 905222
  • 905395
• UPC Code:
  • 0375834127019
  • 0375834126012
  • 0375834128016

Pharmacological Class

• Arteriolar Vasodilation [PE]
• Arteriolar Vasodilator [EPC]

Medicade Reported Pricing

75834012701 HYDRALAZINE 50 MG TABLET

Pricing Unit: EA | Drug Type:

75834012700 HYDRALAZINE 50 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Hydralazine" or generic name "Hydralazine Hydrochloride"

NDC	Brand Name	Generic Name
70518-1581	Hydralazine	Hydralazine
75834-128	Hydralazine	Hydralazine
75834-126	Hydralazine	Hydralazine
75834-127	Hydralazine	Hydralazine
55154-1490	Hydralazine	Hydralazine
55154-1487	Hydralazine	Hydralazine
0404-9875	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride
0404-9986	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride
0517-0901	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0615-0516	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0615-0531	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0615-0532	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0615-5649	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0615-7973	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0641-6231	HydrALAZINE hydrochloride	HydrALAZINE hydrochloride
0904-6440	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0904-6441	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0904-6442	Hydralazine Hydrochloride	Hydralazine Hydrochloride
0904-6443	Hydralazine Hydrochloride	Hydralazine Hydrochloride
17478-834	Hydralazine Hydrochloride	Hydralazine Hydrochloride
17478-934	Hydralazine Hydrochloride	Hydralazine Hydrochloride
21695-679	HYDRALAZINE HYDROCHLORIDE	Hydralazine Hydrochloride
21695-680	HYDRALAZINE HYDROCHLORIDE	Hydralazine Hydrochloride
21695-694	HYDRALAZINE HYDROCHLORIDE	Hydralazine Hydrochloride
21695-695	HYDRALAZINE HYDROCHLORIDE	Hydralazine Hydrochloride