Buspirone Hydrochloride

Product NDC
70518-3279
11-digit product format
705183279
Labeler code
70518
Product ID
70518-3279_4ee0757f-6beb-b16e-e063-6394a90a65bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2021-11-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 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
A210907-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14
A210907-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14
A210907-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14
A210907-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210907-001AB
A210907-002AB
A210907-003AB
A210907-004AB

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 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210907-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210907-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210907-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210907-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210907-004AB1d06236e962d9…

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
6c6db7a9-a728-406a-81af-edd89e1cc26fAvailable 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
70518-3279-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-3279-1Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3279-0EA - Each70518-3279e8f283fe-8d1e-4ab0-9f2d-a38a90a6087c12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3279BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240316_6c6db7a9-a728-406a-81af-edd89e1cc26f.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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnit Dose Solutions, Inc.544a4570-bd7f-72bb-e063-6394a90ab8d62026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.fbff8248-b73c-474e-907e-449f8316c6292026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAsclemed USA, Inc.97f2d082-0931-4e4f-a5be-7792e399e42b2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECoupler LLC510120d3-c922-a071-e063-6294a90af6a72026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.5b4da3f8-a5ce-4699-92e1-37fb95e0af2d2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.6c6db7a9-a728-406a-81af-edd89e1cc26f2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
ndc (product): 70518-3279
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.824c80e6-d508-405f-8a4f-2f10df5a9dc82026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.187c315b-9c2c-485f-aa63-e399e0796e782026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.068ee1a0-a77a-4803-bad9-18117d7fb3582026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.18ddef0b-1451-4bea-94fb-b6ec27f4744b2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.ed2b56fe-e02f-46bc-808a-352f9bbb5b572025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions48b4e52d-d4c4-4d24-a0ac-24316371cef02025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP801803eb-be17-4064-8813-7ccf52316cde2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HCLBUSPIRONE HCLDirect_Rx3246dd4d-f787-2f62-e063-6294a90a9cd22025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HCLBUSPIRONE HCLDirect_Rx37780596-3b6f-8d00-e063-6294a90ad4ad2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.335107c9-5799-c4df-e063-6294a90a5ca02025-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackb6352207-e708-44a7-8a63-93b96613e1e72025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30c93022-4126-db8c-e063-6394a90a75792025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HCLBUSPIRONE HCLDirect_Rxf71e019b-3928-f8eb-e053-6394a90a871e2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.f98d258d-6479-253a-e053-6394a90acbb32025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN6c6db7a9-a728-406a-81af-edd89e1cc26f7
866083buspirone hydrochloride 10 MG Oral TabletSCD6c6db7a9-a728-406a-81af-edd89e1cc26f7
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY6c6db7a9-a728-406a-81af-edd89e1cc26f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3279-07051832790030 TABLET in 1 BLISTER PACK (70518-3279-0) 30 tablet2021-11-300000-00-00NoNoCurrent
70518-3279-17051832790130 TABLET in 1 BLISTER PACK (70518-3279-1) 30 tablet2025-07-31NoNoCurrent