busPIRone HCl

Product NDC
69238-1118
Requested package NDC
69238-1118-6
11-digit product format
692381118
Labeler code
69238
Product ID
69238-1118_f697167a-4d7c-42fb-91c0-7c1f877bf54a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69238-111869238-1118-6DDiscontinued by firm2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69238-111869238-1118-6DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1118-1EA - Each69238-1118b02e171d-465f-46c4-93ce-acd18d97cf2512019-06-19
69238-1118-5EA - Each69238-1118c6d4de0e-5779-43cf-961f-2ae2db44800b12019-06-19
69238-1118-6EA - Each69238-1118eecc0e93-ac07-4554-a097-75dd5ceffa4b12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1118BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]8Legacy NDC20241205_33999f17-f689-40a1-955a-fb19c0590e0e.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
69238-1118-66923811180660 TABLET in 1 BOTTLE (69238-1118-6) 60 tablet2017-05-240000-00-00NoNoCurrent