Hydralazine Hydrochloride 10 mg/1
Hydralazine Hydrochloride · TABLET · Coupler LLC
Hydralazine Hydrochloride is a tablet containing hydralazine hydrochloride at 10 mg/1, taken oral. Manufactured by Coupler LLC.
Key Facts
- Brand Name
- Hydralazine Hydrochloride
- Generic Name
- Hydralazine Hydrochloride
- NDC Code (Product)
67046-1609- Manufacturer
- Coupler LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205236
- Marketing Start
- 10/22/2025
Recall History
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.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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.
SKY PACKAGING
Failed Impurities/Degradation Specifications
Amerisource Health Services LLC
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Par Pharmaceutical Inc.
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
SKY PACKAGING
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.
Dosage & Administration
DOSAGE AND ADMINISTRATION Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE hydrochloride tablets. In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE hydrochloride tablets combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.
Warnings
WARNINGS In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .)
Contraindications
CONTRAINDICATIONS Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent: Digestive: constipation, paralytic ileus. Cardiovascular: hypotension, paradoxical pressor response, edema. Respiratory: dyspnea. Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary: difficulty in urination. Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitive Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other: nasal congestion, flushing, lacrimation, conjunctivitis.
Frequently Asked Questions
What is Hydralazine Hydrochloride used for?
Hydralazine Hydrochloride contains Hydralazine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Hydralazine Hydrochloride a controlled substance?
Hydralazine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Hydralazine Hydrochloride?
The generic name for Hydralazine Hydrochloride is Hydralazine Hydrochloride. There are 5 other brand versions of Hydralazine Hydrochloride.
What is the NDC code for Hydralazine Hydrochloride 10 mg/1?
The NDC (National Drug Code) for Hydralazine Hydrochloride 10 mg/1 is 67046-1609, listed by Coupler LLC.