FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
68382-181
11-digit product format
683820181
Labeler code
68382
Product ID
68382-181_8692aee8-7eb4-4cbb-8a31-3ecc49660195
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078888
Marketing category
ANDA
Marketing start
2014-05-03
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE10 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
68382-181-01Buspirone hydrochloride100 in 1 BOTTLETABLET10011
68382-181-05Buspirone hydrochloride500 in 1 BOTTLETABLET50011
68382-181-10Buspirone hydrochloride1000 in 1 BOTTLETABLET100011
68382-181-30Buspirone hydrochloride1 in 1 BLISTER PACKTABLET111
68382-181-77Buspirone hydrochloride100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-181-01EA - Each68382-181b05258c8-ae6f-401b-8450-fafdb007d9dd12014-10-03
68382-181-05EA - Each68382-181600a201c-792f-4569-a721-817f094028d112014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-181BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 5 package rows20250214_14fd7c1c-778e-46d4-9024-89b319f15f39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN897dac69-a59b-423c-be16-6301c7e504d913
866083buspirone hydrochloride 10 MG Oral TabletSCD897dac69-a59b-423c-be16-6301c7e504d913
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY897dac69-a59b-423c-be16-6301c7e504d913
866083busPIRone HCl 10 MG Oral TabletPSN14fd7c1c-778e-46d4-9024-89b319f15f3911
866018busPIRone HCl 15 MG Oral TabletPSN14fd7c1c-778e-46d4-9024-89b319f15f3911
866090busPIRone HCl 30 MG Oral TabletPSN14fd7c1c-778e-46d4-9024-89b319f15f3911
866094busPIRone HCl 5 MG Oral TabletPSN14fd7c1c-778e-46d4-9024-89b319f15f3911
866111busPIRone HCl 7.5 MG Oral TabletPSN14fd7c1c-778e-46d4-9024-89b319f15f3911
866083buspirone hydrochloride 10 MG Oral TabletSCD14fd7c1c-778e-46d4-9024-89b319f15f3911
866018buspirone hydrochloride 15 MG Oral TabletSCD14fd7c1c-778e-46d4-9024-89b319f15f3911
866090buspirone hydrochloride 30 MG Oral TabletSCD14fd7c1c-778e-46d4-9024-89b319f15f3911
866094buspirone hydrochloride 5 MG Oral TabletSCD14fd7c1c-778e-46d4-9024-89b319f15f3911
866111buspirone hydrochloride 7.5 MG Oral TabletSCD14fd7c1c-778e-46d4-9024-89b319f15f3911
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY14fd7c1c-778e-46d4-9024-89b319f15f3911
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY14fd7c1c-778e-46d4-9024-89b319f15f3911
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY14fd7c1c-778e-46d4-9024-89b319f15f3911
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY14fd7c1c-778e-46d4-9024-89b319f15f3911
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY14fd7c1c-778e-46d4-9024-89b319f15f3911
866083busPIRone HCl 10 MG Oral TabletPSNe80d83a6-7c2a-478e-bdf1-c481824fc3013
866018busPIRone HCl 15 MG Oral TabletPSNe80d83a6-7c2a-478e-bdf1-c481824fc3013
866111busPIRone HCl 7.5 MG Oral TabletPSNe80d83a6-7c2a-478e-bdf1-c481824fc3013
866083buspirone hydrochloride 10 MG Oral TabletSCDe80d83a6-7c2a-478e-bdf1-c481824fc3013
866018buspirone hydrochloride 15 MG Oral TabletSCDe80d83a6-7c2a-478e-bdf1-c481824fc3013
866111buspirone hydrochloride 7.5 MG Oral TabletSCDe80d83a6-7c2a-478e-bdf1-c481824fc3013
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYe80d83a6-7c2a-478e-bdf1-c481824fc3013
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYe80d83a6-7c2a-478e-bdf1-c481824fc3013
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYe80d83a6-7c2a-478e-bdf1-c481824fc3013
866083busPIRone HCl 10 MG Oral TabletPSNa0aa6344-3a88-4726-b621-7fb3b930be3e1
866083buspirone hydrochloride 10 MG Oral TabletSCDa0aa6344-3a88-4726-b621-7fb3b930be3e1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYa0aa6344-3a88-4726-b621-7fb3b930be3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-181-0168382018101100 TABLET in 1 BOTTLE (68382-181-01) 100 tablet2014-05-030000-00-00NoNoCurrent
68382-181-0568382018105500 TABLET in 1 BOTTLE (68382-181-05) 500 tablet2014-05-030000-00-00NoNoCurrent
68382-181-10683820181101000 TABLET in 1 BOTTLE (68382-181-10) 1000 tablet2014-05-030000-00-00NoNoCurrent
68382-181-30683820181301 in 1 BLISTER PACKHistorical
68382-181-7768382018177100 BLISTER PACK in 1 CARTON (68382-181-77) / 1 TABLET in 1 BLISTER PACK (68382-181-30) 100 blister pack2014-05-030000-00-00NoNoCurrent