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: Aphena Pharma Solutions - Tennessee, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 45c637b7-3057-ea38-e063-6394a90a87b6
SPL ID: 45c63c90-30a3-54ff-e063-6394a90af15f
Version: 1
Effective date: 2025-12-12
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:19:05

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 · 12 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		Aphena Pharma Solutions - Tennessee, LLC	openfda.manufacturer_name
ndc	package	71610-975-60	openfda.package_ndc
ndc	product	71610-975	openfda.product_ndc
ndc11	package	71610097560	derived:openfda.package_ndc
rxcui		866018	openfda.rxcui
spl id		45c63c90-30a3-54ff-e063-6394a90af15f	id
spl set id		45c637b7-3057-ea38-e063-6394a90a87b6	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

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.