FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
0093-5200
11-digit product format
000935200
Labeler code
0093
Product ID
0093-5200_f2a05d58-ca70-4b89-aa19-6b63e85a57a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075022
Marketing category
ANDA
Marketing start
2004-03-26
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

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

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
0093-5200-05Buspirone Hydrochloride500 in 1 BOTTLETABLET50019
0093-5200-06Buspirone Hydrochloride60 in 1 BOTTLETABLET6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5200-05EA - Each0093-5200a2494f74-ca90-4d6f-a364-59b35083cc4712012-07-24
0093-5200-06EA - Each0093-5200ea46a296-cfa0-44a9-9005-a563a3398f6b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]11
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5200BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]19Current NDC, Legacy NDC, 2 package rows20230731_6fac36b4-b223-479e-913f-f8c9cdb9e119.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN6fac36b4-b223-479e-913f-f8c9cdb9e11919
866018busPIRone HCl 15 MG Oral TabletPSN6fac36b4-b223-479e-913f-f8c9cdb9e11919
866090busPIRone HCl 30 MG Oral TabletPSN6fac36b4-b223-479e-913f-f8c9cdb9e11919
866094busPIRone HCl 5 MG Oral TabletPSN6fac36b4-b223-479e-913f-f8c9cdb9e11919
866083buspirone hydrochloride 10 MG Oral TabletSCD6fac36b4-b223-479e-913f-f8c9cdb9e11919
866018buspirone hydrochloride 15 MG Oral TabletSCD6fac36b4-b223-479e-913f-f8c9cdb9e11919
866090buspirone hydrochloride 30 MG Oral TabletSCD6fac36b4-b223-479e-913f-f8c9cdb9e11919
866094buspirone hydrochloride 5 MG Oral TabletSCD6fac36b4-b223-479e-913f-f8c9cdb9e11919
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY6fac36b4-b223-479e-913f-f8c9cdb9e11919
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY6fac36b4-b223-479e-913f-f8c9cdb9e11919
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY6fac36b4-b223-479e-913f-f8c9cdb9e11919
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY6fac36b4-b223-479e-913f-f8c9cdb9e11919
866090busPIRone HCl 30 MG Oral TabletPSN4adc1750-b89e-473d-a18f-949423a2354f9
866090buspirone hydrochloride 30 MG Oral TabletSCD4adc1750-b89e-473d-a18f-949423a2354f9
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY4adc1750-b89e-473d-a18f-949423a2354f9
866090busPIRone HCl 30 MG Oral TabletPSN58623499-9552-4101-bdf4-ce9227aa6bdc7
866090buspirone hydrochloride 30 MG Oral TabletSCD58623499-9552-4101-bdf4-ce9227aa6bdc7
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY58623499-9552-4101-bdf4-ce9227aa6bdc7
866090busPIRone HCl 30 MG Oral TabletPSNd5fcc60d-5465-4075-948c-1aa4ff21af4c2
866090buspirone hydrochloride 30 MG Oral TabletSCDd5fcc60d-5465-4075-948c-1aa4ff21af4c2
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYd5fcc60d-5465-4075-948c-1aa4ff21af4c2
866090busPIRone HCl 30 MG Oral TabletPSNa8720833-3bbc-4714-b9b8-716c5e55410d1
866090buspirone hydrochloride 30 MG Oral TabletSCDa8720833-3bbc-4714-b9b8-716c5e55410d1
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYa8720833-3bbc-4714-b9b8-716c5e55410d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5200-0500093520005500 TABLET in 1 BOTTLE (0093-5200-05) 500 tablet2004-03-260000-00-00NoNoCurrent
0093-5200-060009352000660 TABLET in 1 BOTTLE (0093-5200-06) 60 tablet2004-03-260000-00-00NoNoCurrent