Buspirone hydrochloride

Product NDC
71335-2237
Requested package NDC
71335-2237-3
11-digit product format
713352237
Labeler code
71335
Product ID
71335-2237_d18097c5-1c0f-4a7d-b1ea-eeed4f02d038
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078888
Marketing category
ANDA
Marketing start
2023-03-21
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 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 43.

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
A078888-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-07
A078888-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-07
A078888-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-07
A078888-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-07
A078888-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A078888-001AB
A078888-002AB
A078888-003AB
A078888-004AB
A078888-005AB

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 5 · 197 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-0784e616aacf4f…
2026-09-14 22:38:342026-08A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-0784e616aacf4f…
2026-09-14 22:38:342026-08A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-0784e616aacf4f…
2026-09-14 22:38:342026-08A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-0784e616aacf4f…
2026-09-14 22:38:342026-08A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-2184e616aacf4f…
2026-08-18 06:07:402026-07A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-2103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 197 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078888-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078888-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078888-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078888-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078888-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A078888-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078888-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078888-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078888-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078888-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078888-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078888-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078888-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078888-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078888-005AB103ed91905a0d…

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 HYDROCHLORIDE7.5 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
866111Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08efb26e-488c-49d4-8432-98db855962e9Available 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
71335-2237-1Buspirone hydrochloride30 in 1 BOTTLETABLET30102
71335-2237-2Buspirone hydrochloride90 in 1 BOTTLETABLET90102
71335-2237-3Buspirone hydrochloride18 in 1 BOTTLETABLET18102
71335-2237-4Buspirone hydrochloride28 in 1 BOTTLETABLET28102
71335-2237-5Buspirone hydrochloride60 in 1 BOTTLETABLET60102
71335-2237-6Buspirone hydrochloride120 in 1 BOTTLETABLET120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2237BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20250402_08efb26e-488c-49d4-8432-98db855962e9.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEMajor Pharmaceuticalsa9bb9216-3dac-4e8a-9df9-f72c2eaef1602026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEUnit Dose Solutions, Inc.544b8918-7175-655f-e063-6394a90a453a2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDECoupler LLC53e7576a-e2f4-042b-e063-6294a90ae0352026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.fa3f9c0e-261d-4ceb-8cc7-e5e0135634792026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC1315494d-7a51-4395-bc7c-afb4bc5482c92026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAvPAKb230197c-3d50-7874-e053-2a95a90af50f2026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEZydus Lifesciences Limited1109dd63-6492-49b1-a383-3ab3a80cd6c72025-12-24Exact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack08efb26e-488c-49d4-8432-98db855962e92025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
ndc (package): 71335-2237-3
ndc (product): 71335-2237
ndc11 (package): 71335223703
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack897dac69-a59b-423c-be16-6301c7e504d92025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.14fd7c1c-778e-46d4-9024-89b319f15f392025-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.7ac98a7f-0ded-427f-899a-c3f6d19974032025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAmerican Health Packaginge80d83a6-7c2a-478e-bdf1-c481824fc3012024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackb07c0a91-892c-47f5-819e-a128e0ef1ed72023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC7f6986a8-59dc-4dc3-bac0-b38cfc689f8f2019-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC310c6bea-838b-43e4-87e0-a0050829c2422018-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSN08efb26e-488c-49d4-8432-98db855962e9102
866111buspirone hydrochloride 7.5 MG Oral TabletSCD08efb26e-488c-49d4-8432-98db855962e9102
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY08efb26e-488c-49d4-8432-98db855962e9102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2237-37133522370318 TABLET in 1 BOTTLE (71335-2237-3) 18 tablet2024-04-03NoNoCurrent