Buspirone hydrochloride

Product NDC
71335-0222
11-digit product format
713350222
Labeler code
71335
Product ID
71335-0222_3fb81009-c15b-4762-a59f-6fda6502a6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078888
Marketing category
ANDA
Marketing start
2014-05-03
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
866083Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
897dac69-a59b-423c-be16-6301c7e504d9Available 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
71335-0222-1Buspirone hydrochloride30 in 1 BOTTLETABLET3013
71335-0222-2Buspirone hydrochloride60 in 1 BOTTLETABLET6013
71335-0222-3Buspirone hydrochloride90 in 1 BOTTLETABLET9013
71335-0222-4Buspirone hydrochloride45 in 1 BOTTLETABLET4513
71335-0222-5Buspirone hydrochloride180 in 1 BOTTLETABLET18013
71335-0222-6Buspirone hydrochloride120 in 1 BOTTLETABLET12013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0222BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 6 package rows20250331_897dac69-a59b-423c-be16-6301c7e504d9.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
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack897dac69-a59b-423c-be16-6301c7e504d92025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078888
application number: ANDA078888
ndc (product): 71335-0222
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
866083busPIRone HCl 10 MG Oral TabletPSN897dac69-a59b-423c-be16-6301c7e504d913
866083buspirone hydrochloride 10 MG Oral TabletSCD897dac69-a59b-423c-be16-6301c7e504d913
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY897dac69-a59b-423c-be16-6301c7e504d913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0222-17133502220130 TABLET in 1 BOTTLE (71335-0222-1) 30 tablet2021-12-270000-00-00NoNoCurrent
71335-0222-27133502220260 TABLET in 1 BOTTLE (71335-0222-2) 60 tablet2019-04-110000-00-00NoNoCurrent
71335-0222-37133502220390 TABLET in 1 BOTTLE (71335-0222-3) 90 tablet2021-12-270000-00-00NoNoCurrent
71335-0222-47133502220445 TABLET in 1 BOTTLE (71335-0222-4) 45 tablet2021-12-270000-00-00NoNoCurrent
71335-0222-571335022205180 TABLET in 1 BOTTLE (71335-0222-5) 180 tablet2021-12-270000-00-00NoNoCurrent
71335-0222-671335022206120 TABLET in 1 BOTTLE (71335-0222-6) 120 tablet2021-12-270000-00-00NoNoCurrent