FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
0093-1003
11-digit product format
000931003
Labeler code
0093
Product ID
0093-1003_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
2002-03-01
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 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
0093-1003-01Buspirone Hydrochloride100 in 1 BOTTLETABLET10019
0093-1003-05Buspirone Hydrochloride500 in 1 BOTTLETABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1003-01EA - Each0093-100362cad0c9-19fb-4793-90b5-a1dfaee7214812012-07-24
0093-1003-05EA - Each0093-10031decf92e-03fa-4f14-a9da-1d348073e3ac12012-07-24

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 [AIDAREX PHARMACEUTICALS LLC]2
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-1003BUSPIRONE 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
866018busPIRone HCl 15 MG Oral TabletPSN1cbe2bbe-56e3-4904-93d9-d9c3c0daa1656
866018buspirone hydrochloride 15 MG Oral TabletSCD1cbe2bbe-56e3-4904-93d9-d9c3c0daa1656
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY1cbe2bbe-56e3-4904-93d9-d9c3c0daa1656
866018busPIRone HCl 15 MG Oral TabletPSN9a702362-39cb-4171-8d64-f37fa7e1f6385
866018busPIRone HCl 15 MG Oral TabletPSNff02c7cb-f96a-4a3b-99a2-812cd78b345c5
866018buspirone hydrochloride 15 MG Oral TabletSCD9a702362-39cb-4171-8d64-f37fa7e1f6385
866018buspirone hydrochloride 15 MG Oral TabletSCDff02c7cb-f96a-4a3b-99a2-812cd78b345c5
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYff02c7cb-f96a-4a3b-99a2-812cd78b345c5
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY9a702362-39cb-4171-8d64-f37fa7e1f6385
866018busPIRone HCl 15 MG Oral TabletPSNcff1c7b2-4edb-4b5a-9626-2f7b8671b0154
866018busPIRone HCl 15 MG Oral TabletPSN2496ccca-57da-4bce-8c22-1dcdd790a1314
866018buspirone hydrochloride 15 MG Oral TabletSCDcff1c7b2-4edb-4b5a-9626-2f7b8671b0154
866018buspirone hydrochloride 15 MG Oral TabletSCD2496ccca-57da-4bce-8c22-1dcdd790a1314
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY2496ccca-57da-4bce-8c22-1dcdd790a1314
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYcff1c7b2-4edb-4b5a-9626-2f7b8671b0154
866083busPIRone HCl 10 MG Oral TabletPSN7edf55c5-1388-4542-a8a5-2a6187afffbd2
866018busPIRone HCl 15 MG Oral TabletPSN7edf55c5-1388-4542-a8a5-2a6187afffbd2
866083buspirone hydrochloride 10 MG Oral TabletSCD7edf55c5-1388-4542-a8a5-2a6187afffbd2
866018buspirone hydrochloride 15 MG Oral TabletSCD7edf55c5-1388-4542-a8a5-2a6187afffbd2
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY7edf55c5-1388-4542-a8a5-2a6187afffbd2
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY7edf55c5-1388-4542-a8a5-2a6187afffbd2
866018busPIRone HCl 15 MG Oral TabletPSNb7e3a98c-9ec5-4c21-9218-0d53a555a75c1
866018busPIRone HCl 15 MG Oral TabletPSNb971e151-4a68-4c01-8f9b-8c56f6bad18a1
866018busPIRone HCl 15 MG Oral TabletPSN7dc7c367-1d73-7634-e053-2a91aa0a9cb91
866018busPIRone HCl 15 MG Oral TabletPSN438f5c4d-a009-b851-e063-6394a90a084a1
866018buspirone hydrochloride 15 MG Oral TabletSCDb7e3a98c-9ec5-4c21-9218-0d53a555a75c1
866018buspirone hydrochloride 15 MG Oral TabletSCDb971e151-4a68-4c01-8f9b-8c56f6bad18a1
866018buspirone hydrochloride 15 MG Oral TabletSCD7dc7c367-1d73-7634-e053-2a91aa0a9cb91
866018buspirone hydrochloride 15 MG Oral TabletSCD438f5c4d-a009-b851-e063-6394a90a084a1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY438f5c4d-a009-b851-e063-6394a90a084a1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYb7e3a98c-9ec5-4c21-9218-0d53a555a75c1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYb971e151-4a68-4c01-8f9b-8c56f6bad18a1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY7dc7c367-1d73-7634-e053-2a91aa0a9cb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-1003-0100093100301100 TABLET in 1 BOTTLE (0093-1003-01) 100 tablet2002-03-010000-00-00NoNoCurrent
0093-1003-0500093100305500 TABLET in 1 BOTTLE (0093-1003-05) 500 tablet2002-03-010000-00-00NoNoCurrent