FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
0378-1175
11-digit product format
003781175
Labeler code
0378
Product ID
0378-1175_bf3ebca4-75bb-4f84-a906-06a1337e190f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076008
Marketing category
ANDA
Marketing start
2001-08-01
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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
Buspirone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094, 866111

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
0378-1175-91Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1175-91EA - Each0378-11758ef8b623-0d7f-4956-b111-ad6429533f2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]12
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]9
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1175BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 1 package rows20240606_7c9eafb9-9ce1-4b28-900c-8fcb4b23424e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866083busPIRone HCl 10 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018busPIRone HCl 15 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866018busPIRone HCl 15 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866090busPIRone HCl 30 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866090busPIRone HCl 30 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094busPIRone HCl 5 MG Oral TabletPSN91bb5fc9-5121-43c2-b2af-149240d4189a22
866094busPIRone HCl 5 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866111busPIRone HCl 7.5 MG Oral TabletPSN7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866083buspirone hydrochloride 10 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866083buspirone hydrochloride 10 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018buspirone hydrochloride 15 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018buspirone hydrochloride 15 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866090buspirone hydrochloride 30 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866090buspirone hydrochloride 30 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094buspirone hydrochloride 5 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094buspirone hydrochloride 5 MG Oral TabletSCD91bb5fc9-5121-43c2-b2af-149240d4189a22
866111buspirone hydrochloride 7.5 MG Oral TabletSCD7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY7c9eafb9-9ce1-4b28-900c-8fcb4b23424e22
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY91bb5fc9-5121-43c2-b2af-149240d4189a22
866083busPIRone HCl 10 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866018busPIRone HCl 15 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866090busPIRone HCl 30 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866094busPIRone HCl 5 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866083buspirone hydrochloride 10 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866018buspirone hydrochloride 15 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866090buspirone hydrochloride 30 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866094buspirone hydrochloride 5 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33
866090busPIRone HCl 30 MG Oral TabletPSN8cf79880-b63f-4412-8b29-8f1c59f849f11
866090busPIRone HCl 30 MG Oral TabletPSN4b044819-2959-4914-b564-d944201246fd1
866090buspirone hydrochloride 30 MG Oral TabletSCD8cf79880-b63f-4412-8b29-8f1c59f849f11
866090buspirone hydrochloride 30 MG Oral TabletSCD4b044819-2959-4914-b564-d944201246fd1
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY8cf79880-b63f-4412-8b29-8f1c59f849f11
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY4b044819-2959-4914-b564-d944201246fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1175-910037811759160 TABLET in 1 BOTTLE, PLASTIC (0378-1175-91) 60 tablet2001-08-010000-00-00NoNoCurrent