Buspirone Hydrochloride

Product NDC
68071-2987
11-digit product format
680712987
Labeler code
68071
Product ID
68071-2987_2dcdccf6-bd84-0ce9-e063-6394a90a0c0e
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
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2987-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2987-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2987-30efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1484e616aacf4f…
2026-08-18 06:07:402026-07A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14caaa826d4ba7…
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…

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
2026-09-14 22:38:342026-08A210907-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210907-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A210907-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A210907-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A210907-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-004AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
f98d258d-6479-253a-e053-6394a90acbb3Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2987-32025-02-10C16284748780-12cef2736-7e12-d83d-e063-dadaa90ab31fBuspirone Hydrochloride Tablets, USP Rx Only
68071-2987-32025-01-30C16284748780-12cef2736-7e12-d83d-e063-dadaa90ab31fBuspirone Hydrochloride Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2987-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2987BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250212_f98d258d-6479-253a-e053-6394a90acbb3.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 HYDROCHLORIDEREMEDYREPACK INC.ed2b56fe-e02f-46bc-808a-352f9bbb5b572026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP801803eb-be17-4064-8813-7ccf52316cde2026-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
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 HYDROCHLORIDEA-S Medication Solutions48b4e52d-d4c4-4d24-a0ac-24316371cef02025-09-09Warnings, 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
ndc (product): 68071-2987

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNf98d258d-6479-253a-e053-6394a90acbb32
866018buspirone hydrochloride 15 MG Oral TabletSCDf98d258d-6479-253a-e053-6394a90acbb32
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf98d258d-6479-253a-e053-6394a90acbb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2987-36807129870330 TABLET in 1 BOTTLE, PLASTIC (68071-2987-3) 30 tablet2023-04-17NoNoCurrent