Buspirone Hydrochloride

Product NDC
50090-4859
11-digit product format
500904859
Labeler code
50090
Product ID
50090-4859_1fb17cdd-bd45-4a28-b42b-8b0b9edee683
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202330
Marketing category
ANDA
Marketing start
2015-06-30
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4859DDiscontinued by firm2026-08-17
excluded packagepackage50090-485950090-4859-1DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-172680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-005AB12680178bc6a6…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4859BUSPIRONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC20230208_6aeaf6e1-cca9-4530-80cc-7fc0dc4f8159.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 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 HYDROCHLORIDEGolden State Medical Supply, Inc.bcce49d3-c8eb-9f9b-e053-2995a90a67d92026-02-18Warnings, 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4859-15009048590160 TABLET in 1 BOTTLE (50090-4859-1) 60 tablet2020-01-220000-00-00NoNoCurrent