Buspirone Hydrochloride

Product NDC
71205-493
11-digit product format
712050493
Labeler code
71205
Product ID
71205-493_db7da29a-36b4-4cdd-a76c-8f140bd5b81b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202330
Marketing category
ANDA
Marketing start
2015-06-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202330-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25
A202330-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25
A202330-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25
A202330-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25
A202330-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202330-001AB
A202330-002AB
A202330-003AB
A202330-004AB
A202330-005AB

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.

Product history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-2584e616aacf4f…
2026-09-14 22:38:342026-08A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-1784e616aacf4f…
2026-08-18 06:07:402026-07A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-1703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202330-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202330-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202330-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A202330-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A202330-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A202330-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202330-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202330-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2027-12-31

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
24a95296-5fbe-49df-b1fe-4760d3a5ffe1Available 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
71205-493-30Buspirone Hydrochloride30 in 1 BOTTLETABLET302
71205-493-60Buspirone Hydrochloride60 in 1 BOTTLETABLET602
71205-493-90Buspirone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-493BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220710_24a95296-5fbe-49df-b1fe-4760d3a5ffe1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEGolden State Medical Supply, Inc.bcce49d3-c8eb-9f9b-e053-2995a90a67d92026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Inc.cb0091ad-97f6-431b-b2b9-e03171eed2742026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.b42cc365-6259-4d2e-9648-d37718b65e1e2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.50b18368-d37c-374b-e063-6394a90a81142026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC093b701d-4a43-4871-b726-c5820fa3ab952026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDIRECT RXbae98d45-e192-56e3-e053-2a95a90aadc32026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionsecdfd79e-7450-40ec-9561-cdda3a0439902026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions4d1ae09a-3ead-4604-8d13-590f41f63b962026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCd9de7cf1-c38d-8b3c-e053-2995a90aa26b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Science Limitedcff9f09a-1ea2-4968-b57b-e62bebaae2382025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1790d63d-ecb1-da9d-e063-6294a90a50ba2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack63e2d4e2-f1ab-480d-b0bb-79b6cdb57a5d2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HCLBUSPIRONE HCLDirect_Rxf83219c9-8081-fe55-e053-6394a90aa9242025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsda6f4a74-a71e-4ccc-af2c-8de29e909c3b2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP24a95296-5fbe-49df-b1fe-4760d3a5ffe12022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
ndc (product): 71205-493
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC0d46cf24-07e1-4bb7-8b5b-5ce12a030afd2022-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC62e4345a-2c51-4f93-89f0-282895ced7852021-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfbab1056-b63e-473e-9259-ba099d884d2b2021-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfa8171d4-f73c-4a91-973d-cb46c55070812021-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN24a95296-5fbe-49df-b1fe-4760d3a5ffe12
866094buspirone hydrochloride 5 MG Oral TabletSCD24a95296-5fbe-49df-b1fe-4760d3a5ffe12
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY24a95296-5fbe-49df-b1fe-4760d3a5ffe12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-493-307120504933030 TABLET in 1 BOTTLE (71205-493-30) 30 tablet2020-10-200000-00-00NoNoCurrent
71205-493-607120504936060 TABLET in 1 BOTTLE (71205-493-60) 60 tablet2020-10-200000-00-00NoNoCurrent
71205-493-907120504939090 TABLET in 1 BOTTLE (71205-493-90) 90 tablet2020-10-200000-00-00NoNoCurrent