Buspirone Hydrochloride

Product NDC
83209-303
Requested package NDC
83209-303-60
11-digit product format
832090303
Labeler code
83209
Product ID
83209-303_438f5c4d-a00a-b851-e063-6394a90a084a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA075022
Marketing category
ANDA
Marketing start
2025-11-13
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075022-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-28
A075022-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-28
A075022-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-28
A075022-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A075022-001AB
A075022-002AB
A075022-003AB
A075022-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075022-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075022-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075022-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075022-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2004-03-25d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075022-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075022-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075022-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075022-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075022-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075022-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075022-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075022-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075022-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075022-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075022-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075022-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075022-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075022-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075022-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075022-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075022-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075022-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075022-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE15 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
866018Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
438f5c4d-a009-b851-e063-6394a90a084aAvailable 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
83209-303-15Buspirone Hydrochloride15 in 1 BLISTER PACKTABLET151
83209-303-20Buspirone Hydrochloride20 in 1 BLISTER PACKTABLET201
83209-303-30Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET301
83209-303-60Buspirone Hydrochloride60 in 1 BLISTER PACKTABLET601

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 HYDROCHLORIDERedpharm Drug5718bc19-07b2-b61d-e063-6394a90a6e802026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC459cc50d-0b18-ac1d-e063-6294a90ae7c42026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCff02c7cb-f96a-4a3b-99a2-812cd78b345c2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale438f5c4d-a009-b851-e063-6394a90a084a2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
ndc (package): 83209-303-60
ndc (product): 83209-303
ndc11 (package): 83209030360
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3b41fd76-c3cc-77f0-e063-6294a90aa7782025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions4adc1750-b89e-473d-a18f-949423a2354f2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacka8720833-3bbc-4714-b9b8-716c5e55410d2024-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsd5fcc60d-5465-4075-948c-1aa4ff21af4c2024-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs72bff09c-826e-4394-a7e7-41d56ce9605b2024-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackdb32a7ec-5b50-4305-8952-df22e7e871e22024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionscff1c7b2-4edb-4b5a-9626-2f7b8671b0152024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONEBoswell Pharmacy Services d/b/a BPS Wholesale18e90d65-4a3a-864e-e063-6294a90ae99d2024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions96789fdc-f3a0-4441-b9f4-2be2d9c6273b2023-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.6fac36b4-b223-479e-913f-f8c9cdb9e1192023-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP864ddd0c-80e5-4b4b-84e9-7d66214464ae2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP9a702362-39cb-4171-8d64-f37fa7e1f6382022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP69eb15e9-c33e-40a3-82d8-497dad13068d2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCefa03f52-430e-455a-bdca-7f9d422b7b192019-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb7e3a98c-9ec5-4c21-9218-0d53a555a75c2018-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075022
application number: ANDA075022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN438f5c4d-a009-b851-e063-6394a90a084a1
866018buspirone hydrochloride 15 MG Oral TabletSCD438f5c4d-a009-b851-e063-6394a90a084a1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY438f5c4d-a009-b851-e063-6394a90a084a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83209-303-608320903036060 TABLET in 1 BLISTER PACK (83209-303-60) 60 tablet2025-11-13NoNoCurrent