FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
70518-3607
11-digit product format
705183607
Labeler code
70518
Product ID
70518-3607_f1763bc1-de62-e5ff-e053-2995a90a316f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208972
Marketing category
ANDA
Marketing start
2023-01-04
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3607DDiscontinued by firm2026-08-03
excluded packagepackage70518-360770518-3607-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-360770518-3607-1DDiscontinued by firm2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208972-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-04-16
A208972-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2019-04-16
A208972-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-04-16
A208972-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-04-16
A208972-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-04-16
A208972-006BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE2.5MGTABLET / ORAL2026-05-13
A208972-007BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE12.5MGTABLET / ORAL2026-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208972-001AB
A208972-002AB
A208972-003AB
A208972-004AB
A208972-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208972-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-006BUSPIRONE HYDROCHLORIDE2.5MGTABLET / ORAL2026-05-13a50c72e98297…
2026-08-01 22:54:322026-06A208972-007BUSPIRONE HYDROCHLORIDE12.5MGTABLET / ORAL2026-05-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208972-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-005AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEIPG Pharmaceuticals, Inc2c516eec-65d9-4481-8823-ae6b6da840622026-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208972
application number: ANDA208972
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC27db85e9-68ef-4d43-a319-4e2ec8dbae052020-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208972
application number: ANDA208972
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEEpic Pharma, LLC02628a0c-bfdb-4a58-8e48-bcd8ca12d53b2019-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208972
application number: ANDA208972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3607-07051836070060 TABLET in 1 BLISTER PACK (70518-3607-0) 60 tablet2023-01-040000-00-00NoNoCurrent