Buspirone Hydrochloride

Product NDC
52959-676
11-digit product format
529590676
Labeler code
52959
Product ID
52959-676_d48ce370-755e-4da3-bd60-fd91433924ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA075022
Marketing category
ANDA
Marketing start
2010-12-23
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
52959-676-03Buspirone Hydrochloride3 in 1 BOTTLETABLET33
52959-676-30Buspirone Hydrochloride30 in 1 BOTTLETABLET303
52959-676-60Buspirone Hydrochloride60 in 1 BOTTLETABLET603
52959-676-90Buspirone Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-676-30EA - Each52959-676b849cd40-b0e1-4565-9ef0-f7359424a90f12015-10-02
52959-676-60EA - Each52959-6761b3f7e19-daac-490a-a9a3-29bc0f39f9b712012-07-24
52959-676-90EA - Each52959-676f745d7f2-d68b-4519-a694-1d2d29a6992912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-676BUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 4 package rows20120423_8351a3c5-e06e-4d27-a504-f36e0b22d41f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN8351a3c5-e06e-4d27-a504-f36e0b22d41f3
866083buspirone hydrochloride 10 MG Oral TabletSCD8351a3c5-e06e-4d27-a504-f36e0b22d41f3
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY8351a3c5-e06e-4d27-a504-f36e0b22d41f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-676-03529590676033 in 1 BOTTLEHistorical
52959-676-305295906763030 in 1 BOTTLEHistorical
52959-676-605295906766060 in 1 BOTTLEHistorical
52959-676-905295906769090 in 1 BOTTLEHistorical