Buspirone Hydrochloride

Product NDC
70518-2031
Requested package NDC
70518-2031-2
11-digit product format
705182031
Labeler code
70518
Product ID
70518-2031_499b44fe-d3dc-219a-e063-6294a90a0428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204582
Marketing category
ANDA
Marketing start
2019-04-18
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-203170518-2031-2DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204582-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18
A204582-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18
A204582-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18
A204582-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204582-001AB
A204582-002AB
A204582-003AB
A204582-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204582-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204582-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204582-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2027-12-31

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
a9fc7091-b3ce-45fd-8d89-aeebdd81c327Available 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
70518-2031-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET3018
70518-2031-1Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET3018
70518-2031-2Buspirone Hydrochloride45 in 1 BOTTLE, PLASTICTABLET4518
70518-2031-3Buspirone Hydrochloride60 in 1 BLISTER PACKTABLET6018
70518-2031-4Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6018
70518-2031-5Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2031BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 6 package rows20250306_a9fc7091-b3ce-45fd-8d89-aeebdd81c327.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.fd05160d-24c6-4371-8b2c-c0f78c8b468e2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.a9fc7091-b3ce-45fd-8d89-aeebdd81c3272026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
ndc (package): 70518-2031-2
ndc (product): 70518-2031
ndc11 (package): 70518203102
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack225575f1-9635-4922-8286-d479d6480bf02026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeee7fa99-a9a1-4299-8a3d-6c2dd90948c92026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC5424f933-93e1-4480-acdf-bd8667ae50e92026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLC1d883a13-4877-c6c7-e063-6294a90a51372025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4ff72575-bd60-40ce-b3a8-fd92b79af6742025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMajor Pharmaceuticals8dc1ee33-e5aa-4462-8fb9-9bbdf54634882025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNa9fc7091-b3ce-45fd-8d89-aeebdd81c32718
866083buspirone hydrochloride 10 MG Oral TabletSCDa9fc7091-b3ce-45fd-8d89-aeebdd81c32718
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYa9fc7091-b3ce-45fd-8d89-aeebdd81c32718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2031-27051820310245 TABLET in 1 BOTTLE, PLASTIC (70518-2031-2) 45 tablet2020-07-280000-00-00NoNoCurrent