FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
23155-023
11-digit product format
231550023
Labeler code
23155
Product ID
23155-023_5cb34079-0b3b-4c4e-b5a8-bfcdb21d7c3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204582
Marketing category
ANDA
Marketing start
2012-06-29
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
23155-023-01Buspirone Hydrochloride100 in 1 BOTTLETABLET10011
23155-023-05Buspirone Hydrochloride500 in 1 BOTTLETABLET50011
23155-023-10Buspirone Hydrochloride1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-023-01EA - Each23155-023292341c3-4edd-4f89-8343-0d1b71c9f4cb12019-04-11
23155-023-05EA - Each23155-023accf7e83-a287-47c5-ab23-0a8335d30e2512019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]3
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-023BUSPIRONE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 3 package rows20230731_4ff72575-bd60-40ce-b3a8-fd92b79af674.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN4ff72575-bd60-40ce-b3a8-fd92b79af67411
866018busPIRone HCl 15 MG Oral TabletPSN4ff72575-bd60-40ce-b3a8-fd92b79af67411
866090busPIRone HCl 30 MG Oral TabletPSN4ff72575-bd60-40ce-b3a8-fd92b79af67411
866094busPIRone HCl 5 MG Oral TabletPSN4ff72575-bd60-40ce-b3a8-fd92b79af67411
866083buspirone hydrochloride 10 MG Oral TabletSCD4ff72575-bd60-40ce-b3a8-fd92b79af67411
866018buspirone hydrochloride 15 MG Oral TabletSCD4ff72575-bd60-40ce-b3a8-fd92b79af67411
866090buspirone hydrochloride 30 MG Oral TabletSCD4ff72575-bd60-40ce-b3a8-fd92b79af67411
866094buspirone hydrochloride 5 MG Oral TabletSCD4ff72575-bd60-40ce-b3a8-fd92b79af67411
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY4ff72575-bd60-40ce-b3a8-fd92b79af67411
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY4ff72575-bd60-40ce-b3a8-fd92b79af67411
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY4ff72575-bd60-40ce-b3a8-fd92b79af67411
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY4ff72575-bd60-40ce-b3a8-fd92b79af67411
866083busPIRone HCl 10 MG Oral TabletPSN8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866094busPIRone HCl 5 MG Oral TabletPSN8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866083buspirone hydrochloride 10 MG Oral TabletSCD8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866094buspirone hydrochloride 5 MG Oral TabletSCD8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866094busPIRone HCl 5 MG Oral TabletPSNbc1aa302-c00b-58aa-e053-2995a90a9d2e2
866094buspirone hydrochloride 5 MG Oral TabletSCDbc1aa302-c00b-58aa-e053-2995a90a9d2e2
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYbc1aa302-c00b-58aa-e053-2995a90a9d2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-023-0123155002301100 TABLET in 1 BOTTLE (23155-023-01) 100 tablet2015-09-180000-00-00NoNoCurrent
23155-023-0523155002305500 TABLET in 1 BOTTLE (23155-023-05) 500 tablet2018-09-200000-00-00NoNoCurrent
23155-023-10231550023101000 TABLET in 1 BOTTLE (23155-023-10) 1000 tablet2018-09-200000-00-00NoNoCurrent