Hydralazine 25 mg/1
HYDRALAZINE HYDROCHLORIDE · TABLET · Nivagen Pharmaceuticals, Inc.
Hydralazine is a tablet containing hydralazine hydrochloride at 25 mg/1, taken oral. Manufactured by Nivagen Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Hydralazine
- Generic Name
- HYDRALAZINE HYDROCHLORIDE
- NDC Code (Product)
75834-126- Manufacturer
- Nivagen Pharmaceuticals, Inc.
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203845
- Marketing Start
- 02/15/2017
Recall History
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Mckesson Medical Surgical
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Fresenius Kabi USA, LLC
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Amerisource Health Services LLC
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Aidapak Services, LLC
Labeling: Label Mixup; HYDRALAZINE HCL Tablet, 25 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD49582_16, EXP: 5/16/2014.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Aidapak Services, LLC
Labeling: Label Mixup; hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 12.5 mg, NDC 00143117101, Pedigree: AD52778_16, EXP: 5/20/2014.
Frequently Asked Questions
What is Hydralazine used for?
Hydralazine contains HYDRALAZINE HYDROCHLORIDE. It is a tablet taken oral. Consult your doctor for specific uses.
Is Hydralazine a controlled substance?
Hydralazine is not classified as a controlled substance by the DEA.
What is the generic name for Hydralazine?
The generic name for Hydralazine is HYDRALAZINE HYDROCHLORIDE. There are 11 other brand versions of HYDRALAZINE HYDROCHLORIDE.
What is the NDC code for Hydralazine 25 mg/1?
The NDC (National Drug Code) for Hydralazine 25 mg/1 is 75834-126, listed by Nivagen Pharmaceuticals, Inc..
Other Hydralazine Dosages
Other Hydralazine Brands
See all →- Hydralazine Hydrochloride10 mg/172162-1535
- HydrALAZINE Hydrochloride10 mg/176282-309
- hydrALAZINE Hydrochloride20 mg/mL84549-614
- HYDRALAZINE HYDROCHLORIDE10 mg/123155-001
- HYDRALAZINE HYDROCHLORIDE25 mg/123155-002
- Hydralazine Hydrochloride100 mg/123155-835
- Hydralazine Hydrochloride50 mg/131722-521
- Hydralazine Hydrochloride10 mg/148433-046
- Hydralazine Hydrochloride50 mg/150090-7212
- Hydralazine Hydrochloride25 mg/150228-183
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)