FDA.reportPublic FDA data

Bucapsol

Product NDC
81279-122
11-digit product format
812790122
Labeler code
81279
Product ID
81279-122_4dc3284b-c414-6249-e063-6394a90a5d7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PANGEA PHARMACEUTICALS, LLC
Application
ANDA218628
Marketing category
ANDA
Marketing start
2026-04-10
Substance
BUSPIRONE
Active strength
7.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bucapsol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTK65WKS8HL
Rxcui2708991, 2708993, 2708994, 2714180, 2714182, 2714184

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
81279-122-30Bucapsol30 in 1 BOTTLECAPSULE305
81279-122-60Bucapsol60 in 1 BOTTLECAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81279-122BUCAPSOL (BUSPIRONE HYDROCHLORIDE) CAPSULE [PANGEA PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250515_f101c5f3-d533-474d-a8bf-90d054933d16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2714182Bucapsol 10 MG Oral CapsulePSNf101c5f3-d533-474d-a8bf-90d054933d165
2714184Bucapsol 15 MG Oral CapsulePSNf101c5f3-d533-474d-a8bf-90d054933d165
2714180Bucapsol 7.5 MG Oral CapsulePSNf101c5f3-d533-474d-a8bf-90d054933d165
2708991busPIRone HCl 10 MG Oral CapsulePSNf101c5f3-d533-474d-a8bf-90d054933d165
2708993busPIRone HCl 15 MG Oral CapsulePSNf101c5f3-d533-474d-a8bf-90d054933d165
2708994busPIRone HCl 7.5 MG Oral CapsulePSNf101c5f3-d533-474d-a8bf-90d054933d165
2714182buspirone hydrochloride 10 MG Oral Capsule [Bucapsol]SBDf101c5f3-d533-474d-a8bf-90d054933d165
2714184buspirone hydrochloride 15 MG Oral Capsule [Bucapsol]SBDf101c5f3-d533-474d-a8bf-90d054933d165
2714180buspirone hydrochloride 7.5 MG Oral Capsule [Bucapsol]SBDf101c5f3-d533-474d-a8bf-90d054933d165
2708991buspirone hydrochloride 10 MG Oral CapsuleSCDf101c5f3-d533-474d-a8bf-90d054933d165
2708993buspirone hydrochloride 15 MG Oral CapsuleSCDf101c5f3-d533-474d-a8bf-90d054933d165
2708994buspirone hydrochloride 7.5 MG Oral CapsuleSCDf101c5f3-d533-474d-a8bf-90d054933d165
2714182Bucapsol 10 MG Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2714184Bucapsol 15 MG Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2714180Bucapsol 7.5 MG Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2708991buspirone HCl 10 MG (equivalent to buspirone 9.1 MG) Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2708991buspirone HCl 10 MG Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2708993buspirone HCl 15 MG (equivalent to buspirone 13.7 MG) Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2708993buspirone HCl 15 MG Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2708994buspirone HCl 7.5 MG (equivalent to buspirone 6.8 MG) Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165
2708994buspirone HCl 7.5 MG Oral CapsuleSYf101c5f3-d533-474d-a8bf-90d054933d165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81279-122-308127901223030 CAPSULE in 1 BOTTLE (81279-122-30) 30 capsule2026-04-10NoNoCurrent
81279-122-608127901226060 CAPSULE in 1 BOTTLE (81279-122-60) 60 capsule2026-04-10NoNoCurrent