Dopamine Hydrochloride and Dextrose
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
- Dopamine Hydrochloride and Dextrose
- Generic name
- DOPAMINE HYDROCHLORIDE
- Manufacturer
- ProPharma Distribution
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3ef116db-fb26-1e66-e063-6294a90a0610
- SPL ID
- 463de4ca-e6b5-8c9a-e063-6394a90a70cd
- Version
- 2
- Effective date
- 2025-12-18
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:08:47
| Harmonized routes |
|---|
| INTRAVENOUS |
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 | NDA | 019615 | derived:openfda.application_number |
| application number | NDA019615 | openfda.application_number | |
| brand name | Dopamine Hydrochloride and Dextrose | openfda.brand_name | |
| generic name | DOPAMINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | ProPharma Distribution | openfda.manufacturer_name | |
| ndc | package | 84549-007-02 | openfda.package_ndc |
| ndc | product | 84549-007 | openfda.product_ndc |
| ndc11 | package | 84549000702 | derived:openfda.package_ndc |
| rxcui | 1743877 | openfda.rxcui | |
| spl id | 463de4ca-e6b5-8c9a-e063-6394a90a70cd | id | |
| spl set id | 3ef116db-fb26-1e66-e063-6294a90a0610 | set_id | |
| unii | 7L3E358N9L | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of dopamine hydrochloride will require substantially reduced dosage. See Drug Interactions , below. Evidence is inadequate for fully defining proper dosage and limitations for use in children. Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Do not add Dopamine Hydrochloride and 5% Dextrose Injection, USP to any alkaline diluent solution since dopamine hydrochloride is inactivated in alkaline solution. Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis. The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excess administration of potassium-free solutions may result in significant hypokalemia.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Cardiovascular System ventricular arrhythmia atrial fibrillation ectopic beats tachycardia anginal pain palpitation cardiac conduction abnormalities widened QRS complex bradycardia hypotension hypertension vasoconstriction Respiratory System dyspnea Gastrointestinal System nausea vomiting Metabolic/Nutritional System azotemia Central Nervous System headache anxiety Dermatological System piloerection Other Gangrene of the extremities has occurred when high doses were administered for prolonged periods or in patients with occlusive vascular disease receiving low doses of dopamine HCl.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.