Buspirone Hydrochloride

Product NDC
68788-7875
11-digit product format
687887875
Labeler code
68788
Product ID
68788-7875_a4ec71b4-e776-40bf-bb57-5dafeb56c826
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075388
Marketing category
ANDA
Marketing start
2021-03-08
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7875DDiscontinued by firm2026-08-03
excluded packagepackage68788-787568788-7875-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-787568788-7875-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-787568788-7875-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-787568788-7875-9DDiscontinued by firm2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075388-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09
A075388-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09
A075388-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075388-001AB
A075388-002AB
A075388-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075388-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2002-05-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075388-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075388-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2002-05-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075388-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075388-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075388-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075388-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075388-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075388-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075388-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075388-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075388-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075388-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075388-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075388-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075388-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075388-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075388-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075388-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075388-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075388-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075388-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075388-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075388-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075388-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075388-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075388-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075388-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075388-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075388-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075388-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075388-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075388-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075388-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075388-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075388-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075388-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075388-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075388-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075388-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075388-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075388-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075388-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.8e0219e9-d305-4473-8229-aee0ee84caf62026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.476f4f55-c6c1-4f39-950e-59236f4995772026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions84621631-4c13-4147-ae3c-4ed30d4ebb372026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.3155e607-bc7f-4e90-9edf-8e862dd5737d2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1521109d-8386-472f-9483-f1fe9f7ed1522026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions338f3317-96c0-4b8a-8299-8ce2a10911ae2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionse4d44e49-eb8f-454e-a737-22caf30bda782025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack49659ee7-ca08-4df1-8e6b-3a366a7839c72025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackaba814f0-55ce-4480-99f1-b9ad1ba77d3f2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackbee0edbf-3fc3-484b-9715-f13a329216ae2025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack4e7640d1-0a31-4f97-82bb-574cf1ff6e4a2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC40d5813d-d040-002c-e063-6294a90a5f7a2025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions7c7225a0-8237-4998-843a-bf10fa6ec65b2025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack2df0b238-14a4-40ca-a235-411f6c9b83382025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackf85b59b7-b945-4440-8378-987bd287a6552025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b217f341-7d51-475d-887f-f16786164c7b2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.270398a0-21b8-407b-af76-4aeef90f72be2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3dd7f213-afd8-67d6-e063-6294a90ac1082025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack65c69118-36bb-4f0d-9669-b52556056ec52025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacked7e334a-cc4a-47b2-a4db-56495730b6982025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075388
application number: ANDA075388

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7875-1EA - Each68788-787560174f84-7004-4f4b-ba52-57620c97af4512021-04-08
68788-7875-3EA - Each68788-7875b9088371-0628-442f-999e-4d8b643af2e012021-04-08
68788-7875-6EA - Each68788-787551fcc0b0-8deb-4301-ac97-8948d14d6dbb12021-04-08
68788-7875-9EA - Each68788-78753abf8b9d-4797-4593-aa2e-06b007f696e212021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7875-168788787501100 TABLET in 1 BOTTLE (68788-7875-1) 100 tablet2021-03-080000-00-00NoNoCurrent
68788-7875-36878878750330 TABLET in 1 BOTTLE (68788-7875-3) 30 tablet2021-03-080000-00-00NoNoCurrent
68788-7875-66878878750660 TABLET in 1 BOTTLE (68788-7875-6) 60 tablet2021-03-080000-00-00NoNoCurrent
68788-7875-96878878750990 TABLET in 1 BOTTLE (68788-7875-9) 90 tablet2021-03-080000-00-00NoNoCurrent