busPIRone HCl

Product NDC
50090-4657
11-digit product format
500904657
Labeler code
50090
Product ID
50090-4657_fe45e4ea-89e8-4b2b-a3c8-814ddfe0c6ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208829
Marketing category
ANDA
Marketing start
2017-05-24
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4657IInactivated by FDA2026-10-05
excluded packagepackage50090-465750090-4657-1IInactivated by FDA2026-10-05
excluded packagepackage50090-465750090-4657-3IInactivated by FDA2026-10-05

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 · 45 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 packagepackage50090-4657-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4657-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4657-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4657-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4657-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4657-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4657-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4657-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4657-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4657-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4657-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4657-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4657-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4657-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4657-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4657-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4657-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4657-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4657-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4657-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4657-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4657-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4657-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4657-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4657-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4657-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4657-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4657-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4657-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4657-11332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208829-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24
A208829-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24
A208829-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24
A208829-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24
A208829-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-08-18 06:07:402026-07A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-2403ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208829-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208829-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208829-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-005AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208829-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-005AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208829-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-005AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-005AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208829-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-005AB15aa47cf7b7d7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4657-1busPIRone HCl60 in 1 BOTTLETABLET606
50090-4657-3busPIRone HCl90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4657-1EA - Each50090-465749dfae55-0aee-44a4-a81d-b964afb8f70612022-12-07
50090-4657-3EA - Each50090-46572084028d-7813-4059-a8ce-5e3c3bd224f212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4657BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210615_130fac8c-27e2-4c67-8e03-63062e509992.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN130fac8c-27e2-4c67-8e03-63062e5099926
866018buspirone hydrochloride 15 MG Oral TabletSCD130fac8c-27e2-4c67-8e03-63062e5099926
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY130fac8c-27e2-4c67-8e03-63062e5099926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4657-15009046570160 TABLET in 1 BOTTLE (50090-4657-1) 60 tablet2019-10-280000-00-00NoNoCurrent
50090-4657-35009046570390 TABLET in 1 BOTTLE (50090-4657-3) 90 tablet2019-10-280000-00-00NoNoCurrent