FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
0093-0054
11-digit product format
000930054
Labeler code
0093
Product ID
0093-0054_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
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

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
0093-0054-01Buspirone Hydrochloride100 in 1 BOTTLETABLET10019
0093-0054-05Buspirone Hydrochloride500 in 1 BOTTLETABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0054-01EA - Each0093-005404bfe0fb-0bfe-4328-ad93-d9ec6e61a2a412012-07-24
0093-0054-05EA - Each0093-0054986ccc25-c78a-435d-9eef-3ee3553ad00d12012-07-24

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 [H.J. HARKINS COMPANY, INC.]3
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]3
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]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
0093-0054BUSPIRONE 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
866083busPIRone HCl 10 MG Oral TabletPSN69eb15e9-c33e-40a3-82d8-497dad13068d5
866083busPIRone HCl 10 MG Oral TabletPSN20e3c81a-ff4f-4691-bf1a-a4e522e7a56f5
866083buspirone hydrochloride 10 MG Oral TabletSCD69eb15e9-c33e-40a3-82d8-497dad13068d5
866083buspirone hydrochloride 10 MG Oral TabletSCD20e3c81a-ff4f-4691-bf1a-a4e522e7a56f5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY20e3c81a-ff4f-4691-bf1a-a4e522e7a56f5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY69eb15e9-c33e-40a3-82d8-497dad13068d5
866083busPIRone HCl 10 MG Oral TabletPSN24d84191-4b29-4a81-a9db-e2d35ee3944f4
866083buspirone hydrochloride 10 MG Oral TabletSCD24d84191-4b29-4a81-a9db-e2d35ee3944f4
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY24d84191-4b29-4a81-a9db-e2d35ee3944f4
866083busPIRone HCl 10 MG Oral TabletPSN8351a3c5-e06e-4d27-a504-f36e0b22d41f3
866083buspirone hydrochloride 10 MG Oral TabletSCD8351a3c5-e06e-4d27-a504-f36e0b22d41f3
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY8351a3c5-e06e-4d27-a504-f36e0b22d41f3
866083busPIRone HCl 10 MG Oral TabletPSN459cc50d-0b18-ac1d-e063-6294a90ae7c42
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 TabletSCD459cc50d-0b18-ac1d-e063-6294a90ae7c42
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 TabletSY459cc50d-0b18-ac1d-e063-6294a90ae7c42
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
866083busPIRone HCl 10 MG Oral TabletPSN96789fdc-f3a0-4441-b9f4-2be2d9c6273b1
866083busPIRone HCl 10 MG Oral TabletPSN3b41fd76-c3cc-77f0-e063-6294a90aa7781
866083busPIRone HCl 10 MG Oral TabletPSN18e90d65-4a3a-864e-e063-6294a90ae99d1
866083buspirone hydrochloride 10 MG Oral TabletSCD96789fdc-f3a0-4441-b9f4-2be2d9c6273b1
866083buspirone hydrochloride 10 MG Oral TabletSCD3b41fd76-c3cc-77f0-e063-6294a90aa7781
866083buspirone hydrochloride 10 MG Oral TabletSCD18e90d65-4a3a-864e-e063-6294a90ae99d1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY96789fdc-f3a0-4441-b9f4-2be2d9c6273b1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY3b41fd76-c3cc-77f0-e063-6294a90aa7781
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY18e90d65-4a3a-864e-e063-6294a90ae99d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0054-0100093005401100 TABLET in 1 BOTTLE (0093-0054-01) 100 tablet2002-02-280000-00-00NoNoCurrent
0093-0054-0500093005405500 TABLET in 1 BOTTLE (0093-0054-05) 500 tablet2002-03-010000-00-00NoNoCurrent