Buspirone hydrochloride

Product NDC
70518-0380
11-digit product format
705180380
Labeler code
70518
Product ID
70518-0380_2b4cb86d-e507-3651-e063-6394a90a8848
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078888
Marketing category
ANDA
Marketing start
2017-04-03
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 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 42.

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 · 192 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2023-03-212680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 192 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078888-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE15 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
866018Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ac98a7f-0ded-427f-899a-c3f6d1997403Available 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
70518-0380-0Buspirone hydrochloride30 in 1 BLISTER PACKTABLET3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0380BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 1 package rows20250112_7ac98a7f-0ded-427f-899a-c3f6d1997403.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
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
ndc (product): 70518-0380
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
866018busPIRone HCl 15 MG Oral TabletPSN7ac98a7f-0ded-427f-899a-c3f6d199740312
866018buspirone hydrochloride 15 MG Oral TabletSCD7ac98a7f-0ded-427f-899a-c3f6d199740312
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY7ac98a7f-0ded-427f-899a-c3f6d199740312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0380-07051803800030 TABLET in 1 BLISTER PACK (70518-0380-0) 30 tablet2017-04-030000-00-00NoNoCurrent