Buspirone Hydrochloride

Product NDC
53002-1424
Requested package NDC
53002-1424-3
11-digit product format
530021424
Labeler code
53002
Product ID
53002-1424_e6d336e8-f391-4ad3-a42d-8c095035b819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075022
Marketing category
ANDA
Marketing start
2002-03-01
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage53002-142453002-1424-3IInactivated by FDA2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1424-32025-01-30C16284748780-12cef2736-9f96-d83d-e063-dadaa90ab31fBusPIRone Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1424-3Buspirone Hydrochloride30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1424BUSPIRONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 1 package rows20220331_2496ccca-57da-4bce-8c22-1dcdd790a131.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN2496ccca-57da-4bce-8c22-1dcdd790a1314
866018buspirone hydrochloride 15 MG Oral TabletSCD2496ccca-57da-4bce-8c22-1dcdd790a1314
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY2496ccca-57da-4bce-8c22-1dcdd790a1314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1424-35300214240330 TABLET in 1 BOTTLE (53002-1424-3) 30 tablet2021-01-010000-00-00NoNoCurrent