FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
0093-0053
11-digit product format
000930053
Labeler code
0093
Product ID
0093-0053_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
2002-02-28
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
0093-0053-01Buspirone Hydrochloride100 in 1 BOTTLETABLET10019
0093-0053-05Buspirone Hydrochloride500 in 1 BOTTLETABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0053-01EA - Each0093-0053bd67eacb-3629-4cf3-bdc6-472a6db08d7812012-07-24
0093-0053-05EA - Each0093-0053e70d29ed-ae78-4b7f-834a-9929b58fab3c12012-07-24

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
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]9
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0053BUSPIRONE 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 TabletPSN72bff09c-826e-4394-a7e7-41d56ce9605b25
866018busPIRone HCl 15 MG Oral TabletPSN72bff09c-826e-4394-a7e7-41d56ce9605b25
866094busPIRone HCl 5 MG Oral TabletPSN72bff09c-826e-4394-a7e7-41d56ce9605b25
866083buspirone hydrochloride 10 MG Oral TabletSCD72bff09c-826e-4394-a7e7-41d56ce9605b25
866018buspirone hydrochloride 15 MG Oral TabletSCD72bff09c-826e-4394-a7e7-41d56ce9605b25
866094buspirone hydrochloride 5 MG Oral TabletSCD72bff09c-826e-4394-a7e7-41d56ce9605b25
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY72bff09c-826e-4394-a7e7-41d56ce9605b25
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY72bff09c-826e-4394-a7e7-41d56ce9605b25
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY72bff09c-826e-4394-a7e7-41d56ce9605b25
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
866083busPIRone HCl 10 MG Oral TabletPSNdb32a7ec-5b50-4305-8952-df22e7e871e26
866094busPIRone HCl 5 MG Oral TabletPSNdb32a7ec-5b50-4305-8952-df22e7e871e26
866083buspirone hydrochloride 10 MG Oral TabletSCDdb32a7ec-5b50-4305-8952-df22e7e871e26
866094buspirone hydrochloride 5 MG Oral TabletSCDdb32a7ec-5b50-4305-8952-df22e7e871e26
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYdb32a7ec-5b50-4305-8952-df22e7e871e26
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYdb32a7ec-5b50-4305-8952-df22e7e871e26
866094busPIRone HCl 5 MG Oral TabletPSN1531bddc-eddd-4d7e-933c-66d4384e91f74
866094busPIRone HCl 5 MG Oral TabletPSN7871cdf8-cf8d-7370-e053-2991aa0af4dc4
866094buspirone hydrochloride 5 MG Oral TabletSCD7871cdf8-cf8d-7370-e053-2991aa0af4dc4
866094buspirone hydrochloride 5 MG Oral TabletSCD1531bddc-eddd-4d7e-933c-66d4384e91f74
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY7871cdf8-cf8d-7370-e053-2991aa0af4dc4
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY1531bddc-eddd-4d7e-933c-66d4384e91f74
866094busPIRone HCl 5 MG Oral TabletPSNefa03f52-430e-455a-bdca-7f9d422b7b192
866094buspirone hydrochloride 5 MG Oral TabletSCDefa03f52-430e-455a-bdca-7f9d422b7b192
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYefa03f52-430e-455a-bdca-7f9d422b7b192
866094busPIRone HCl 5 MG Oral TabletPSN864ddd0c-80e5-4b4b-84e9-7d66214464ae1
866094buspirone hydrochloride 5 MG Oral TabletSCD864ddd0c-80e5-4b4b-84e9-7d66214464ae1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY864ddd0c-80e5-4b4b-84e9-7d66214464ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0053-0100093005301100 TABLET in 1 BOTTLE (0093-0053-01) 100 tablet2002-02-280000-00-00NoNoCurrent
0093-0053-0500093005305500 TABLET in 1 BOTTLE (0093-0053-05) 500 tablet2002-03-010000-00-00NoNoCurrent