Buspirone Hydrochloride

Product NDC
64980-654
11-digit product format
649800654
Labeler code
64980
Product ID
64980-654_66cf8d73-ea13-47fe-be0f-45edd9101d2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA075413
Marketing category
ANDA
Marketing start
2026-02-27
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
A075413-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-19
A075413-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-19
A075413-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-19
A075413-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2025-10-06
A075413-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2025-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075413-001AB
A075413-002AB
A075413-003AB
A075413-004AB
A075413-005AB

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 4 · 139 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-1984e616aacf4f…
2026-09-14 22:38:342026-08A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-1984e616aacf4f…
2026-09-14 22:38:342026-08A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-1984e616aacf4f…
2026-09-14 22:38:342026-08A075413-004BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2025-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A075413-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2025-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-004BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2025-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2025-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-004BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2025-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2025-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-004BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2025-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2025-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2002-03-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2002-03-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2002-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2002-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2002-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2002-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2002-03-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2002-03-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2002-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2002-03-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2002-03-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2002-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2002-03-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2002-03-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2002-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2002-03-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2002-03-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075413-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2002-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075413-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2002-03-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075413-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2002-03-19d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075413-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075413-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075413-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A075413-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A075413-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A075413-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075413-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075413-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075413-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075413-005AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075413-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075413-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075413-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075413-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075413-005AB1a50c72e98297…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE30 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866018Internal RxNorm lookup
866083Internal RxNorm lookup
866090Internal RxNorm lookup
866094Internal RxNorm lookup
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
b9aa144c-cb36-4069-9eaa-7c150298cdd7Available 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
64980-654-06Buspirone Hydrochloride60 in 1 BOTTLETABLET601
64980-654-50Buspirone Hydrochloride500 in 1 BOTTLETABLET5001

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDERising Pharma Holdings, Inc.b9aa144c-cb36-4069-9eaa-7c150298cdd72026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075413
application number: ANDA075413
ndc (product): 64980-654

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNb9aa144c-cb36-4069-9eaa-7c150298cdd71
866018busPIRone HCl 15 MG Oral TabletPSNb9aa144c-cb36-4069-9eaa-7c150298cdd71
866090busPIRone HCl 30 MG Oral TabletPSNb9aa144c-cb36-4069-9eaa-7c150298cdd71
866094busPIRone HCl 5 MG Oral TabletPSNb9aa144c-cb36-4069-9eaa-7c150298cdd71
866111busPIRone HCl 7.5 MG Oral TabletPSNb9aa144c-cb36-4069-9eaa-7c150298cdd71
866083buspirone hydrochloride 10 MG Oral TabletSCDb9aa144c-cb36-4069-9eaa-7c150298cdd71
866018buspirone hydrochloride 15 MG Oral TabletSCDb9aa144c-cb36-4069-9eaa-7c150298cdd71
866090buspirone hydrochloride 30 MG Oral TabletSCDb9aa144c-cb36-4069-9eaa-7c150298cdd71
866094buspirone hydrochloride 5 MG Oral TabletSCDb9aa144c-cb36-4069-9eaa-7c150298cdd71
866111buspirone hydrochloride 7.5 MG Oral TabletSCDb9aa144c-cb36-4069-9eaa-7c150298cdd71
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYb9aa144c-cb36-4069-9eaa-7c150298cdd71
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYb9aa144c-cb36-4069-9eaa-7c150298cdd71
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYb9aa144c-cb36-4069-9eaa-7c150298cdd71
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYb9aa144c-cb36-4069-9eaa-7c150298cdd71
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYb9aa144c-cb36-4069-9eaa-7c150298cdd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-654-066498006540660 TABLET in 1 BOTTLE (64980-654-06) 60 tablet2026-02-27NoNoCurrent
64980-654-5064980065450500 TABLET in 1 BOTTLE (64980-654-50) 500 tablet2026-02-27NoNoCurrent