Buspirone Hydrochloride

Product NDC
51407-202
11-digit product format
514070202
Labeler code
51407
Product ID
51407-202_f1d67082-8730-261f-e053-2a95a90a87f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply
Application
ANDA202330
Marketing category
ANDA
Marketing start
2014-08-25
Marketing end
2023-11-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51407-202DDiscontinued by firm2026-08-17
excluded packagepackage51407-20251407-202-01DDiscontinued by firm2026-08-17
excluded packagepackage51407-20251407-202-05DDiscontinued by firm2026-08-17

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 · 36 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 packagepackage51407-202-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51407-202-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51407-202-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51407-202-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51407-202-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51407-202-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51407-202-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51407-202-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51407-202-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51407-202-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51407-202-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51407-202-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51407-202-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51407-202-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51407-202-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51407-202-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51407-202-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51407-202-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51407-202-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51407-202-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51407-202-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51407-202-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51407-202-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51407-202-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202330-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25
A202330-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25
A202330-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25
A202330-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25
A202330-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202330-001AB
A202330-002AB
A202330-003AB
A202330-004AB
A202330-005AB

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-005BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-02-172680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202330-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202330-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202330-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202330-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202330-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202330-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202330-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202330-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202330-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202330-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202330-005AB12680178bc6a6…

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
51407-202-01EA - Each51407-202e7a70184-77d4-4e17-bba8-7e6b6e2490f712019-06-19
51407-202-05EA - Each51407-20270c814a5-5d0f-4554-bd6b-3b40fe00d05112019-06-19

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Inc.cb0091ad-97f6-431b-b2b9-e03171eed2742026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.b42cc365-6259-4d2e-9648-d37718b65e1e2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.50b18368-d37c-374b-e063-6394a90a81142026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC093b701d-4a43-4871-b726-c5820fa3ab952026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDIRECT RXbae98d45-e192-56e3-e053-2a95a90aadc32026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEGolden State Medical Supply, Inc.bcce49d3-c8eb-9f9b-e053-2995a90a67d92026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionsecdfd79e-7450-40ec-9561-cdda3a0439902026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions4d1ae09a-3ead-4604-8d13-590f41f63b962026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCd9de7cf1-c38d-8b3c-e053-2995a90aa26b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Science Limitedcff9f09a-1ea2-4968-b57b-e62bebaae2382025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1790d63d-ecb1-da9d-e063-6294a90a50ba2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack63e2d4e2-f1ab-480d-b0bb-79b6cdb57a5d2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HCLBUSPIRONE HCLDirect_Rxf83219c9-8081-fe55-e053-6394a90aa9242025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsda6f4a74-a71e-4ccc-af2c-8de29e909c3b2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP24a95296-5fbe-49df-b1fe-4760d3a5ffe12022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC0d46cf24-07e1-4bb7-8b5b-5ce12a030afd2022-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC62e4345a-2c51-4f93-89f0-282895ced7852021-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfbab1056-b63e-473e-9259-ba099d884d2b2021-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfa8171d4-f73c-4a91-973d-cb46c55070812021-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202330
application number: ANDA202330

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN5975ba77-cf91-4696-98df-72b3ee33e3ba1
866083buspirone hydrochloride 10 MG Oral TabletSCD5975ba77-cf91-4696-98df-72b3ee33e3ba1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY5975ba77-cf91-4696-98df-72b3ee33e3ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-202-0151407020201100 TABLET in 1 BOTTLE (51407-202-01) 100 tablet2019-05-130000-00-00NoNoCurrent
51407-202-0551407020205500 TABLET in 1 BOTTLE (51407-202-05) 500 tablet2019-05-130000-00-00NoNoCurrent