Buspirone Hydrochloride

Product NDC
68071-2572
Requested package NDC
68071-2572-3
11-digit product format
680712572
Labeler code
68071
Product ID
68071-2572_d0d8d05c-b496-65d8-e053-2a95a90ae19b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2019-11-14
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage68071-257268071-2572-3IInactivated by FDA2026-08-10

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
A210907-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14
A210907-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14
A210907-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14
A210907-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210907-001AB
A210907-002AB
A210907-003AB
A210907-004AB

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 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210907-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210907-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210907-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-004AB1d06236e962d9…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2572-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303
68071-2572-6Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET603
68071-2572-8Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2572BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 3 package rows20230718_d0d8d05c-b495-65d8-e053-2a95a90ae19b.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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnit Dose Solutions, Inc.544a4570-bd7f-72bb-e063-6394a90ab8d62026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.fbff8248-b73c-474e-907e-449f8316c6292026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAsclemed USA, Inc.97f2d082-0931-4e4f-a5be-7792e399e42b2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECoupler LLC510120d3-c922-a071-e063-6294a90af6a72026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.5b4da3f8-a5ce-4699-92e1-37fb95e0af2d2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.6c6db7a9-a728-406a-81af-edd89e1cc26f2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.824c80e6-d508-405f-8a4f-2f10df5a9dc82026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.187c315b-9c2c-485f-aa63-e399e0796e782026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.068ee1a0-a77a-4803-bad9-18117d7fb3582026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.18ddef0b-1451-4bea-94fb-b6ec27f4744b2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.ed2b56fe-e02f-46bc-808a-352f9bbb5b572025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions48b4e52d-d4c4-4d24-a0ac-24316371cef02025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP801803eb-be17-4064-8813-7ccf52316cde2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HCLBUSPIRONE HCLDirect_Rx3246dd4d-f787-2f62-e063-6294a90a9cd22025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HCLBUSPIRONE HCLDirect_Rx37780596-3b6f-8d00-e063-6294a90ad4ad2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.335107c9-5799-c4df-e063-6294a90a5ca02025-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackb6352207-e708-44a7-8a63-93b96613e1e72025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30c93022-4126-db8c-e063-6394a90a75792025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HCLBUSPIRONE HCLDirect_Rxf71e019b-3928-f8eb-e053-6394a90a871e2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.f98d258d-6479-253a-e053-6394a90acbb32025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNd0d8d05c-b495-65d8-e053-2a95a90ae19b3
866083buspirone hydrochloride 10 MG Oral TabletSCDd0d8d05c-b495-65d8-e053-2a95a90ae19b3
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYd0d8d05c-b495-65d8-e053-2a95a90ae19b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2572-36807125720330 TABLET in 1 BOTTLE, PLASTIC (68071-2572-3) 30 tablet2021-11-150000-00-00NoNoCurrent