Buspirone Hydrochloride

Product NDC
68071-3336
Requested package NDC
68071-3336-9
11-digit product format
680713336
Labeler code
68071
Product ID
68071-3336_1cd71696-d959-be3e-e063-6394a90a28c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202557
Marketing category
ANDA
Marketing start
2016-12-15
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202557-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30
A202557-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30
A202557-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30
A202557-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-30
A202557-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202557-001AB
A202557-002AB
A202557-003AB
A202557-004AB
A202557-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202557-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202557-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202557-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202557-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
207LT9J9OCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866083Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
540e9b7e-09ff-2cca-e054-00144ff8d46cAvailable on FDA.report

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
68071-3336-3Buspirone Hydrochloride30 in 1 BOTTLETABLET305
68071-3336-6Buspirone Hydrochloride60 in 1 BOTTLETABLET605
68071-3336-9Buspirone Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3336BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240711_540e9b7e-09ff-2cca-e054-00144ff8d46c.zip

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack66df7f74-5dea-46d6-9ef8-9bab37baf4072026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7db10b76-4520-496e-b450-66a662cc95f62026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDIRECT RXbae98d45-e192-56e3-e053-2a95a90aadc32026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDirect_Rx8e9c0553-c994-f54a-e053-2a95a90a6fa32026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCf318ba7b-121f-2e4f-e053-2a95a90a60c52026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAccord Healthcare Inc.3da22999-f5fb-49fd-acde-c3006598e9852025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.540e9b7e-09ff-2cca-e054-00144ff8d46c2024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
ndc (package): 68071-3336-9
ndc (product): 68071-3336
ndc11 (package): 68071333609
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions4ae45cb1-8612-4006-b12c-2440160132ac2023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfac49d42-7bc0-435f-bce2-2548dcdd6de62018-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8b6e7ae6-5b83-4a5a-ab45-cf4be4287d782018-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN540e9b7e-09ff-2cca-e054-00144ff8d46c5
866083buspirone hydrochloride 10 MG Oral TabletSCD540e9b7e-09ff-2cca-e054-00144ff8d46c5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY540e9b7e-09ff-2cca-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3336-96807133360990 TABLET in 1 BOTTLE (68071-3336-9) 90 tablet2017-07-110000-00-00NoNoCurrent