Buspirone Hydrochloride

Product NDC
63629-3333
Requested package NDC
63629-3333-6
11-digit product format
636293333
Labeler code
63629
Product ID
63629-3333_35775dd8-6973-41ab-b1ee-f8b7c1fabb31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075022
Marketing category
ANDA
Marketing start
2004-03-26
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-333363629-3333-6DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3333-1EA - Each63629-333333b77ffc-aa9c-44c8-89bf-8b044a6d32b012012-07-24
63629-3333-2EA - Each63629-33336d8a1172-efad-4155-96c8-26879bfc29a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3333-66362933330615 TABLET in 1 BOTTLE (63629-3333-6) 15 tablet2009-02-050000-00-00NoNoCurrent