Buspirone Hydrochloride

Product NDC
55154-0285
11-digit product format
551540285
Labeler code
55154
Product ID
55154-0285_ef90af23-d97e-4094-971b-1d8114218b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076008
Marketing category
ANDA
Marketing start
2026-09-02
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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
A076008-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-28
A076008-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2013-07-08
A076008-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-01
A076008-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-01
A076008-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076008-001AB
A076008-003AB
A076008-004AB
A076008-005AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2013-07-0884e616aacf4f…
2026-09-14 22:38:342026-08A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-0184e616aacf4f…
2026-09-14 22:38:342026-08A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2013-07-08caaa826d4ba7…
2026-08-18 06:07:402026-07A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-2803ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 212 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076008-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076008-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076008-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A076008-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A076008-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076008-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076008-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076008-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076008-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076008-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076008-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076008-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076008-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076008-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076008-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076008-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-002AB12680178bc6a6…

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 HYDROCHLORIDE5 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866083Internal RxNorm lookup
866094Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef90af23-d97e-4094-971b-1d8114218b10Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLCef90af23-d97e-4094-971b-1d8114218b102026-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076008
application number: ANDA076008
ndc (product): 55154-0285
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076008
application number: ANDA076008
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMylan Pharmaceuticals Inc.7c9eafb9-9ce1-4b28-900c-8fcb4b23424e2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076008
application number: ANDA076008
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDESafecor Health, LLCebda05ee-d895-4636-bc28-d393e69c91b32026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076008
application number: ANDA076008
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMylan Institutional Inc.91bb5fc9-5121-43c2-b2af-149240d4189a2025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076008
application number: ANDA076008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-0285-05515402850010 BLISTER PACK in 1 BAG (55154-0285-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2026-09-02NoNoCurrent