Buspirone 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 (canonical bytes are SHA-256 checked before publication)

Brand name: Buspirone hydrochloride
Generic name: BUSPIRONE HYDROCHLORIDE
Manufacturer: A-S Medication Solutions
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9
SPL ID: 6c194e4a-6e28-4dd2-b133-c42460a507d3
Version: 2
Effective date: 2026-07-24
Source export date: 2026-10-12
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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:32:56

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	202087	derived:openfda.application_number
application number		ANDA202087	openfda.application_number
brand name		Buspirone hydrochloride	openfda.brand_name
generic name		BUSPIRONE HYDROCHLORIDE	openfda.generic_name
manufacturer name		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-8018-1	openfda.package_ndc
ndc	package	50090-8018-2	openfda.package_ndc
ndc	product	50090-8018	openfda.product_ndc
ndc11	package	50090801802	derived:openfda.package_ndc
ndc11	package	50090801801	derived:openfda.package_ndc
rxcui		866094	openfda.rxcui
spl id		6c194e4a-6e28-4dd2-b133-c42460a507d3	id
spl set id		7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9	set_id
unii		207LT9J9OC	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride tablets has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride tablets not be used concomitantly with an MAOI.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS (See also PRECAUTIONS ) Commonly Observed The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.