busPIRone HCl

Product NDC
55700-803
11-digit product format
557000803
Labeler code
55700
Product ID
55700-803_67dcfccf-988c-4554-b9a6-1d05602eb15e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA208829
Marketing category
ANDA
Marketing start
2019-10-11
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-803DDiscontinued by firm2026-10-05
excluded packagepackage55700-80355700-803-60DDiscontinued 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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-803-60DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-803-60DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-803-60DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-803-60DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-803-60DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-803-60DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-803-60DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-803-60DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-803-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-803-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-803-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-803-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-803-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-803-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-803-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55700-803-60IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55700-803-60IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55700-803-60IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55700-803-60IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-803-602025-01-13C16284748780-1ba0f9c33-5cc4-a910-e053-dadaa90a0b85Buspirone Hydrochloride Tablets, USP Rx only
55700-803-602021-01-29C16284748780-1ba0f9c33-5cc4-a910-e053-dadaa90a0b85Buspirone Hydrochloride Tablets, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-803-60EA - Each55700-80310109a25-1f43-4a02-9110-5ad959b733df12019-12-10