FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
63629-2414
11-digit product format
636292414
Labeler code
63629
Product ID
63629-2414_f8962a3c-fd6d-4241-bcf1-4f42b419d9b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078302
Marketing category
ANDA
Marketing start
2020-05-01
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078302-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2007-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078302-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078302-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2007-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078302-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.476f4f55-c6c1-4f39-950e-59236f4995772026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1521109d-8386-472f-9483-f1fe9f7ed1522026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeb072818-3ca8-430b-91a1-e7fedd37990c2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions38677cd0-2ee6-4c8f-8553-36310b2813a12025-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack790b6159-c03b-4a3a-be6b-add35a3114a42025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEOxford Pharmaceuticals, LLC97fcebc1-6615-4b9d-b0f3-6434850f407c2025-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack696911d8-e97a-4c8e-9341-782b4c63bf032024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack8bb7991e-ab09-4602-b49d-0a72a501685b2024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
ndc (product): 63629-2414

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE30 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
866090Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8bb7991e-ab09-4602-b49d-0a72a501685bAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2414-1Buspirone Hydrochloride500 in 1 BOTTLETABLET500106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2414-1EA - Each63629-24141b5ddee2-8500-4e30-8955-222df837bf5712021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2414BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20240807_8bb7991e-ab09-4602-b49d-0a72a501685b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSN8bb7991e-ab09-4602-b49d-0a72a501685b106
866090buspirone hydrochloride 30 MG Oral TabletSCD8bb7991e-ab09-4602-b49d-0a72a501685b106
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY8bb7991e-ab09-4602-b49d-0a72a501685b106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2414-163629241401500 TABLET in 1 BOTTLE (63629-2414-1) 500 tablet2021-02-240000-00-00NoNoCurrent