FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
77771-236
11-digit product format
777710236
Labeler code
77771
Product ID
77771-236_3f66a40c-b9b2-06d4-e063-6294a90a9dda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Radha Pharmaceuticals, Inc.
Application
ANDA202087
Marketing category
ANDA
Marketing start
2025-09-18
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202087-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-12-16
A202087-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-12-16
A202087-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-12-16
A202087-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-12-16
A202087-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2025-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202087-001AB
A202087-002AB
A202087-003AB
A202087-004AB
A202087-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202087-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-12-16a50c72e98297…
2026-08-01 22:54:322026-06A202087-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-12-16a50c72e98297…
2026-08-01 22:54:322026-06A202087-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-12-16a50c72e98297…
2026-08-01 22:54:322026-06A202087-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-12-16a50c72e98297…
2026-08-01 22:54:322026-06A202087-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2025-07-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202087-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202087-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202087-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202087-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202087-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAiPing Pharmaceutical, Inc.55810b17-4796-49d0-90e4-8e075d62eda42026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202087
application number: ANDA202087
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions7b222cb0-0061-4a3e-9d0f-e9f120e7f5d92026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202087
application number: ANDA202087
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC427ad27e-6664-afee-e063-6394a90a18902026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202087
application number: ANDA202087
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC45c637b7-3057-ea38-e063-6394a90a87b62025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202087
application number: ANDA202087
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC424d81f0-b195-5bc2-e063-6394a90a21042025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202087
application number: ANDA202087
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDERadha Pharmaceuticals, Inc.3f66a3fe-9d73-180c-e063-6394a90aacca2025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202087
application number: ANDA202087
ndc (product): 77771-236
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEEPIC PHARMA, LLCe8f43c66-f8de-419f-9ea9-43ddc4ec07982025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202087
application number: ANDA202087

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
207LT9J9OCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866018Internal RxNorm lookup
866083Internal RxNorm lookup
866090Internal RxNorm lookup
866094Internal RxNorm lookup
866111Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f66a3fe-9d73-180c-e063-6394a90aaccaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9968269-ddf2-400e-9170-7376dcf3545aProduct name120251215
2cf3c2e9-d566-c982-009a-188fe4f776b9Product name820200428
4a9096ce-7b98-89e5-5942-15f48c4f7abfProduct name520190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77771-236-01Buspirone hydrochloride100 in 1 BOTTLETABLET1001
77771-236-05Buspirone hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-236-01EA - Each77771-23653cf88b2-20d3-4506-822e-063de279130812025-10-14
77771-236-05EA - Each77771-2360b8decdd-4377-452c-b474-cefd9068840812025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN427ad27e-6664-afee-e063-6394a90a18903
866083buspirone hydrochloride 10 MG Oral TabletSCD427ad27e-6664-afee-e063-6394a90a18903
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY427ad27e-6664-afee-e063-6394a90a18903
866083busPIRone HCl 10 MG Oral TabletPSN3f66a3fe-9d73-180c-e063-6394a90aacca1
866018busPIRone HCl 15 MG Oral TabletPSN3f66a3fe-9d73-180c-e063-6394a90aacca1
866090busPIRone HCl 30 MG Oral TabletPSN3f66a3fe-9d73-180c-e063-6394a90aacca1
866094busPIRone HCl 5 MG Oral TabletPSN3f66a3fe-9d73-180c-e063-6394a90aacca1
866111busPIRone HCl 7.5 MG Oral TabletPSN3f66a3fe-9d73-180c-e063-6394a90aacca1
866083buspirone hydrochloride 10 MG Oral TabletSCD3f66a3fe-9d73-180c-e063-6394a90aacca1
866018buspirone hydrochloride 15 MG Oral TabletSCD3f66a3fe-9d73-180c-e063-6394a90aacca1
866090buspirone hydrochloride 30 MG Oral TabletSCD3f66a3fe-9d73-180c-e063-6394a90aacca1
866094buspirone hydrochloride 5 MG Oral TabletSCD3f66a3fe-9d73-180c-e063-6394a90aacca1
866111buspirone hydrochloride 7.5 MG Oral TabletSCD3f66a3fe-9d73-180c-e063-6394a90aacca1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY3f66a3fe-9d73-180c-e063-6394a90aacca1
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY3f66a3fe-9d73-180c-e063-6394a90aacca1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY3f66a3fe-9d73-180c-e063-6394a90aacca1
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY3f66a3fe-9d73-180c-e063-6394a90aacca1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY3f66a3fe-9d73-180c-e063-6394a90aacca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77771-236-0177771023601100 TABLET in 1 BOTTLE (77771-236-01) 100 tablet2025-09-18NoNoCurrent
77771-236-0577771023605500 TABLET in 1 BOTTLE (77771-236-05) 500 tablet2025-09-18NoNoCurrent