Buspirone Hydrochloride

Product NDC
0378-1145
11-digit product format
003781145
Labeler code
0378
Product ID
0378-1145_d6848975-7bf9-4227-a73c-2631d8b050be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076008
Marketing category
ANDA
Marketing start
2013-07-08
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
8 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-1145DDiscontinued by firm2026-08-07
excluded packagepackage0378-11450378-1145-01DDiscontinued by firm2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2001-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2013-07-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-003BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-004BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-005BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2001-03-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076008-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076008-005AB15bbf6a4d5a75…

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
0378-1145-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1145-01EA - Each0378-1145081900c5-1d31-450f-b112-3362a585040312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1145BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]20Legacy NDC, 1 package rows20240606_7c9eafb9-9ce1-4b28-900c-8fcb4b23424e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd2026-06-22Warnings, 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018busPIRone HCl 15 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866090busPIRone HCl 30 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094busPIRone HCl 5 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866111busPIRone HCl 7.5 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866083buspirone hydrochloride 10 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018buspirone hydrochloride 15 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866090buspirone hydrochloride 30 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094buspirone hydrochloride 5 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866111buspirone hydrochloride 7.5 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866111busPIRone HCl 7.5 MG Oral TabletPSNea4fc29e-35f6-43ca-aeb1-f323b2d926f91
866111buspirone hydrochloride 7.5 MG Oral TabletSCDea4fc29e-35f6-43ca-aeb1-f323b2d926f91
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYea4fc29e-35f6-43ca-aeb1-f323b2d926f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1145-0100378114501100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01) 100 tablet2013-07-310000-00-00NoNoCurrent