FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
71610-943
Requested package NDC
71610-943-60
11-digit product format
716100943
Labeler code
71610
Product ID
71610-943_3e4b22e7-e800-e5b1-e063-6294a90a6d49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075388
Marketing category
ANDA
Marketing start
2020-07-27
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075388-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09
A075388-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09
A075388-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075388-001AB
A075388-002AB
A075388-003AB

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 22:54:322026-06A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09a50c72e98297…
2026-08-01 22:54:322026-06A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09a50c72e98297…
2026-08-01 22:54:322026-06A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075388-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075388-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075388-003AB1a50c72e98297…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.8e0219e9-d305-4473-8229-aee0ee84caf62026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.476f4f55-c6c1-4f39-950e-59236f4995772026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions84621631-4c13-4147-ae3c-4ed30d4ebb372026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.3155e607-bc7f-4e90-9edf-8e862dd5737d2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1521109d-8386-472f-9483-f1fe9f7ed1522026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions338f3317-96c0-4b8a-8299-8ce2a10911ae2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionse4d44e49-eb8f-454e-a737-22caf30bda782025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack49659ee7-ca08-4df1-8e6b-3a366a7839c72025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackaba814f0-55ce-4480-99f1-b9ad1ba77d3f2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackbee0edbf-3fc3-484b-9715-f13a329216ae2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack4e7640d1-0a31-4f97-82bb-574cf1ff6e4a2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC40d5813d-d040-002c-e063-6294a90a5f7a2025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions7c7225a0-8237-4998-843a-bf10fa6ec65b2025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack2df0b238-14a4-40ca-a235-411f6c9b83382025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackf85b59b7-b945-4440-8378-987bd287a6552025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b217f341-7d51-475d-887f-f16786164c7b2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.270398a0-21b8-407b-af76-4aeef90f72be2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3dd7f213-afd8-67d6-e063-6294a90ac1082025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
ndc (package): 71610-943-60
ndc (product): 71610-943
ndc11 (package): 71610094360
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack65c69118-36bb-4f0d-9669-b52556056ec52025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacked7e334a-cc4a-47b2-a4db-56495730b6982025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866094Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3dd7f213-afd8-67d6-e063-6294a90ac108Available 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
71610-943-53Buspirone Hydrochloride60 in 1 BOTTLETABLET602
71610-943-60Buspirone Hydrochloride90 in 1 BOTTLETABLET902
71610-943-80Buspirone Hydrochloride180 in 1 BOTTLETABLET1802
71610-943-92Buspirone Hydrochloride270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-943-53EA - Each71610-9430fb4ed43-520c-4c13-84f0-bce3ea81c1aa12025-10-14
71610-943-60EA - Each71610-9439471d51f-412f-42c4-ba1c-fe71215c175912025-10-14
71610-943-80EA - Each71610-94342315a2b-b15b-46a9-a3f1-b6cbbb00473112025-10-14
71610-943-92EA - Each71610-943e440d354-d394-45ab-9e3e-f7e717cddb5312025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN3dd7f213-afd8-67d6-e063-6294a90ac1082
866094buspirone hydrochloride 5 MG Oral TabletSCD3dd7f213-afd8-67d6-e063-6294a90ac1082
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY3dd7f213-afd8-67d6-e063-6294a90ac1082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-943-607161009436090 TABLET in 1 BOTTLE (71610-943-60) 90 tablet2025-09-02NoNoCurrent