Hydralazine Hydrochloride
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Hydralazine Hydrochloride
- Generic name
- HYDRALAZINE HYDROCHLORIDE
- Manufacturer
- Proficient Rx LP
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 63f388e0-9f3d-4902-990c-9a105aa098ad
- SPL ID
- 8abc5903-cbd2-436d-b229-4e76d3726e09
- Version
- 4
- Effective date
- 2020-09-01
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:46
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 086242 | derived:openfda.application_number |
| application number | ANDA086242 | openfda.application_number | |
| brand name | Hydralazine Hydrochloride | openfda.brand_name | |
| generic name | HYDRALAZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Proficient Rx LP | openfda.manufacturer_name | |
| ndc | package | 63187-901-60 | openfda.package_ndc |
| ndc | package | 63187-901-30 | openfda.package_ndc |
| ndc | package | 63187-901-90 | openfda.package_ndc |
| ndc | product | 63187-901 | openfda.product_ndc |
| ndc11 | package | 63187090190 | derived:openfda.package_ndc |
| ndc11 | package | 63187090130 | derived:openfda.package_ndc |
| ndc11 | package | 63187090160 | derived:openfda.package_ndc |
| rxcui | 905225 | openfda.rxcui | |
| spl id | 8abc5903-cbd2-436d-b229-4e76d3726e09 | id | |
| spl set id | 63f388e0-9f3d-4902-990c-9a105aa098ad | set_id | |
| unii | FD171B778Y | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 .)
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.