Buspirone Hydrochloride

Product NDC
68071-3834
Requested package NDC
68071-3834-3
11-digit product format
680713834
Labeler code
68071
Product ID
68071-3834_335107d2-e2ba-835d-e063-6394a90a9142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-10-17
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
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…

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
335107c9-5799-c4df-e063-6294a90a5ca0Available 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
68071-3834-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3834BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250423_335107c9-5799-c4df-e063-6294a90a5ca0.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
ndc (package): 68071-3834-3
ndc (product): 68071-3834
ndc11 (package): 68071383403
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
866018busPIRone HCl 15 MG Oral TabletPSN335107c9-5799-c4df-e063-6294a90a5ca01
866018buspirone hydrochloride 15 MG Oral TabletSCD335107c9-5799-c4df-e063-6294a90a5ca01
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY335107c9-5799-c4df-e063-6294a90a5ca01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3834-36807138340330 TABLET in 1 BOTTLE, PLASTIC (68071-3834-3) 30 tablet2025-04-21NoNoCurrent