FDA.reportPublic FDA data

Buspirone HCl

Product NDC
0591-0658
11-digit product format
005910658
Labeler code
0591
Product ID
0591-0658_71a042fc-d5d4-4190-b309-81bc1b95be02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074253
Marketing category
ANDA
Marketing start
2001-03-28
Marketing end
2019-03-31
Substance
BUSPIRONE HYDRO
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0658-01EA - Each0591-0658cf5c9ea0-1c9a-4d15-bd9d-a40eb41c2d1012012-07-24
0591-0658-05EA - Each0591-0658aa74d013-6186-4dd8-9d6d-0ea7511b130a12012-07-24
0591-0658-10EA - Each0591-065802a0574b-4d1a-4af5-a6a9-3c349334fd9b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.]5
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]5
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]5
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]5
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS]4
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS]4
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
Buspirone hydrochlorideACTIVE INGREDIENT207LT9J9OCBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]1
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
BuspironeACTIVE MOIETYTK65WKS8HLBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN36087ac2-e281-4126-b43e-1dee2bba0e648
866018busPIRone HCl 15 MG Oral TabletPSN36087ac2-e281-4126-b43e-1dee2bba0e648
866083buspirone hydrochloride 10 MG Oral TabletSCD36087ac2-e281-4126-b43e-1dee2bba0e648
866018buspirone hydrochloride 15 MG Oral TabletSCD36087ac2-e281-4126-b43e-1dee2bba0e648
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY36087ac2-e281-4126-b43e-1dee2bba0e648
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY36087ac2-e281-4126-b43e-1dee2bba0e648
866083busPIRone HCl 10 MG Oral TabletPSNf61184d1-e34a-4a84-9432-a7bacf09e8185
866083busPIRone HCl 10 MG Oral TabletPSNf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866018busPIRone HCl 15 MG Oral TabletPSNf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866018busPIRone HCl 15 MG Oral TabletPSNf61184d1-e34a-4a84-9432-a7bacf09e8185
866094busPIRone HCl 5 MG Oral TabletPSNf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866083buspirone hydrochloride 10 MG Oral TabletSCDf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866083buspirone hydrochloride 10 MG Oral TabletSCDf61184d1-e34a-4a84-9432-a7bacf09e8185
866018buspirone hydrochloride 15 MG Oral TabletSCDf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866018buspirone hydrochloride 15 MG Oral TabletSCDf61184d1-e34a-4a84-9432-a7bacf09e8185
866094buspirone hydrochloride 5 MG Oral TabletSCDf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYf61184d1-e34a-4a84-9432-a7bacf09e8185
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf61184d1-e34a-4a84-9432-a7bacf09e8185
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYf35ec9aa-2be6-40c9-9112-b9e3b80f8fa85
866083busPIRone HCl 10 MG Oral TabletPSNed60a885-6b02-48c8-979f-27d371e91d6e4
866094busPIRone HCl 5 MG Oral TabletPSNed60a885-6b02-48c8-979f-27d371e91d6e4
866083buspirone hydrochloride 10 MG Oral TabletSCDed60a885-6b02-48c8-979f-27d371e91d6e4
866094buspirone hydrochloride 5 MG Oral TabletSCDed60a885-6b02-48c8-979f-27d371e91d6e4
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYed60a885-6b02-48c8-979f-27d371e91d6e4
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYed60a885-6b02-48c8-979f-27d371e91d6e4
866083busPIRone HCl 10 MG Oral TabletPSN0f67e593-2c33-54d5-e054-00144ff88e881
866083busPIRone HCl 10 MG Oral TabletPSN0eefdd8d-7745-47ae-a204-f35687f3db111
866083busPIRone HCl 10 MG Oral TabletPSN76c01dda-5c87-4c58-b8b5-7fa42b8f3f541
866018busPIRone HCl 15 MG Oral TabletPSN0eefdd8d-7745-47ae-a204-f35687f3db111
866094busPIRone HCl 5 MG Oral TabletPSN0eefdd8d-7745-47ae-a204-f35687f3db111
866083buspirone hydrochloride 10 MG Oral TabletSCD76c01dda-5c87-4c58-b8b5-7fa42b8f3f541
866083buspirone hydrochloride 10 MG Oral TabletSCD0f67e593-2c33-54d5-e054-00144ff88e881
866083buspirone hydrochloride 10 MG Oral TabletSCD0eefdd8d-7745-47ae-a204-f35687f3db111
866018buspirone hydrochloride 15 MG Oral TabletSCD0eefdd8d-7745-47ae-a204-f35687f3db111
866094buspirone hydrochloride 5 MG Oral TabletSCD0eefdd8d-7745-47ae-a204-f35687f3db111
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY76c01dda-5c87-4c58-b8b5-7fa42b8f3f541
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY0f67e593-2c33-54d5-e054-00144ff88e881
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY0eefdd8d-7745-47ae-a204-f35687f3db111
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY0eefdd8d-7745-47ae-a204-f35687f3db111
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY0eefdd8d-7745-47ae-a204-f35687f3db111