Buspirone HCl

Product NDC
0115-1692
11-digit product format
001151692
Labeler code
0115
Product ID
0115-1692_307898af-364b-4f12-8644-016c6d267c6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Impax Generics
Application
ANDA074253
Marketing category
ANDA
Marketing start
2016-11-01
Marketing end
2020-08-31
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0115-1692DDiscontinued by firm2026-08-07
excluded packagepackage0115-16920115-1692-02DDiscontinued by firm2026-08-07
excluded packagepackage0115-16920115-1692-13DDiscontinued by firm2026-08-07
excluded packagepackage0115-16920115-1692-19DDiscontinued 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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1692-19d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1692-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0115-1692-13d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1692-19f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1692-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1692-13f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1692-192ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1692-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1692-132ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1692-19a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1692-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1692-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1692-19cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1692-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1692-13cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1692-19cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1692-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1692-13cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1692-19302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1692-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1692-13302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1692-19ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1692-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1692-13ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1692-190efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1692-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1692-130efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1692-19ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1692-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1692-13ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1692-19367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1692-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1692-13367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1692-19557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1692-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1692-13557ba5c1ecfa…9c80585c8c6e…

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
A074253-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-28
A074253-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-28
A074253-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074253-001AB
A074253-002AB
A074253-003AB

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 UTC2026-02A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074253-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2001-03-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074253-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2002-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074253-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2001-03-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074253-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074253-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074253-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074253-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074253-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074253-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074253-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074253-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074253-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074253-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074253-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074253-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074253-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074253-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074253-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074253-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074253-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074253-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074253-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074253-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1692-02EA - Each0115-1692877920f9-34f0-4d1d-8481-dc477684b19512016-12-07
0115-1692-13EA - Each0115-1692b6884a91-2272-48d3-978c-94426796241e12017-03-06
0115-1692-19EA - Each0115-16929957692b-0076-4e63-97cb-ebeab16f924312016-12-07