FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
42806-832
11-digit product format
428060832
Labeler code
42806
Product ID
42806-832_160f52d2-2e08-4969-80c3-c653767652f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA218628
Marketing category
ANDA
Marketing start
2025-03-13
Substance
BUSPIRONE
Active strength
10 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218628-001BUCAPSOLBUSPIRONE HYDROCHLORIDE7.5MGCAPSULE / ORAL2025-03-13
A218628-002BUCAPSOLBUSPIRONE HYDROCHLORIDE10MGCAPSULE / ORAL2025-03-13
A218628-003BUCAPSOLBUSPIRONE HYDROCHLORIDE15MGCAPSULE / ORALRS2025-03-13
A218628-004BUCAPSOLBUSPIRONE HYDROCHLORIDE5MGCAPSULE / ORAL2026-04-29

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
2026-02-19 14:30 UTC2026-02A218628-001BUCAPSOL7.5MGCAPSULE / ORAL2025-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218628-002BUCAPSOL10MGCAPSULE / ORAL2025-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218628-003BUCAPSOL15MGCAPSULE / ORALRS2025-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218628-001BUCAPSOL7.5MGCAPSULE / ORAL2025-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218628-002BUCAPSOL10MGCAPSULE / ORAL2025-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218628-003BUCAPSOL15MGCAPSULE / ORALRS2025-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A218628-001BUSPIRONE HYDROCHLORIDE7.5MGCAPSULE / ORAL2025-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218628-002BUSPIRONE HYDROCHLORIDE10MGCAPSULE / ORAL2025-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218628-003BUSPIRONE HYDROCHLORIDE15MGCAPSULE / ORAL2025-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218628-001BUSPIRONE HYDROCHLORIDE7.5MGCAPSULE / ORAL2025-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218628-002BUSPIRONE HYDROCHLORIDE10MGCAPSULE / ORAL2025-03-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218628-003BUSPIRONE HYDROCHLORIDE15MGCAPSULE / ORAL2025-03-13fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218628-001BUCAPSOL7.5MGCAPSULE / ORAL2025-03-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218628-002BUCAPSOL10MGCAPSULE / ORAL2025-03-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218628-003BUCAPSOL15MGCAPSULE / ORALRS2025-03-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218628-004BUCAPSOL5MGCAPSULE / ORAL2026-04-29a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TK65WKS8HLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2708991Internal RxNorm lookup
2708993Internal RxNorm lookup
2708994Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
160f52d2-2e08-4969-80c3-c653767652f0Available 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
42806-832-01Buspirone Hydrochloride100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-832BUSPIRONE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]1Current NDC, 1 package rows20250323_160f52d2-2e08-4969-80c3-c653767652f0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BucapsolBUSPIRONE HYDROCHLORIDEPANGEA PHARMACEUTICALS, LLCf101c5f3-d533-474d-a8bf-90d054933d162026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218628
application number: ANDA218628
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEEPIC PHARMA, LLC160f52d2-2e08-4969-80c3-c653767652f02025-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218628
application number: ANDA218628
ndc (product): 42806-832

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2708991busPIRone HCl 10 MG Oral CapsulePSN160f52d2-2e08-4969-80c3-c653767652f01
2708993busPIRone HCl 15 MG Oral CapsulePSN160f52d2-2e08-4969-80c3-c653767652f01
2708994busPIRone HCl 7.5 MG Oral CapsulePSN160f52d2-2e08-4969-80c3-c653767652f01
2708991buspirone hydrochloride 10 MG Oral CapsuleSCD160f52d2-2e08-4969-80c3-c653767652f01
2708993buspirone hydrochloride 15 MG Oral CapsuleSCD160f52d2-2e08-4969-80c3-c653767652f01
2708994buspirone hydrochloride 7.5 MG Oral CapsuleSCD160f52d2-2e08-4969-80c3-c653767652f01
2708991buspirone HCl 10 MG (equivalent to buspirone 9.1 MG) Oral CapsuleSY160f52d2-2e08-4969-80c3-c653767652f01
2708991buspirone HCl 10 MG Oral CapsuleSY160f52d2-2e08-4969-80c3-c653767652f01
2708993buspirone HCl 15 MG (equivalent to buspirone 13.7 MG) Oral CapsuleSY160f52d2-2e08-4969-80c3-c653767652f01
2708993buspirone HCl 15 MG Oral CapsuleSY160f52d2-2e08-4969-80c3-c653767652f01
2708994buspirone HCl 7.5 MG (equivalent to buspirone 6.8 MG) Oral CapsuleSY160f52d2-2e08-4969-80c3-c653767652f01
2708994buspirone HCl 7.5 MG Oral CapsuleSY160f52d2-2e08-4969-80c3-c653767652f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42806-832-0142806083201100 CAPSULE in 1 BOTTLE (42806-832-01) 100 capsule2025-03-13NoNoCurrent