FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
16729-200
11-digit product format
167290200
Labeler code
16729
Product ID
16729-200_4092e48b-b3d6-abf3-e063-6394a90afe61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202557
Marketing category
ANDA
Marketing start
2016-12-15
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, 866111

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
16729-200-01Buspirone Hydrochloride100 in 1 BOTTLETABLET10013
16729-200-16Buspirone Hydrochloride500 in 1 BOTTLETABLET50013
16729-200-17Buspirone Hydrochloride1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-200-01EA - Each16729-20041a09d80-dec4-4d42-8bfb-77b3a51c7ae612016-12-07
16729-200-16EA - Each16729-20063ff7837-df75-4012-9b93-dbc1adb345a112016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]2
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-200BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]12Current NDC, Legacy NDC, 3 package rows20240517_3da22999-f5fb-49fd-acde-c3006598e985.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN3da22999-f5fb-49fd-acde-c3006598e98513
866018busPIRone HCl 15 MG Oral TabletPSN3da22999-f5fb-49fd-acde-c3006598e98513
866090busPIRone HCl 30 MG Oral TabletPSN3da22999-f5fb-49fd-acde-c3006598e98513
866094busPIRone HCl 5 MG Oral TabletPSN3da22999-f5fb-49fd-acde-c3006598e98513
866111busPIRone HCl 7.5 MG Oral TabletPSN3da22999-f5fb-49fd-acde-c3006598e98513
866083buspirone hydrochloride 10 MG Oral TabletSCD3da22999-f5fb-49fd-acde-c3006598e98513
866018buspirone hydrochloride 15 MG Oral TabletSCD3da22999-f5fb-49fd-acde-c3006598e98513
866090buspirone hydrochloride 30 MG Oral TabletSCD3da22999-f5fb-49fd-acde-c3006598e98513
866094buspirone hydrochloride 5 MG Oral TabletSCD3da22999-f5fb-49fd-acde-c3006598e98513
866111buspirone hydrochloride 7.5 MG Oral TabletSCD3da22999-f5fb-49fd-acde-c3006598e98513
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY3da22999-f5fb-49fd-acde-c3006598e98513
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY3da22999-f5fb-49fd-acde-c3006598e98513
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY3da22999-f5fb-49fd-acde-c3006598e98513
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY3da22999-f5fb-49fd-acde-c3006598e98513
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY3da22999-f5fb-49fd-acde-c3006598e98513
866094busPIRone HCl 5 MG Oral TabletPSN8e9c0553-c994-f54a-e053-2a95a90a6fa35
866094buspirone hydrochloride 5 MG Oral TabletSCD8e9c0553-c994-f54a-e053-2a95a90a6fa35
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8e9c0553-c994-f54a-e053-2a95a90a6fa35
866094busPIRone HCl 5 MG Oral TabletPSN8b6e7ae6-5b83-4a5a-ab45-cf4be4287d781
866094busPIRone HCl 5 MG Oral TabletPSN8e85d869-fe78-3148-e053-2995a90a207c1
866094busPIRone HCl 5 MG Oral TabletPSN4f5855b7-d3d4-3477-e054-00144ff8d46c1
866094buspirone hydrochloride 5 MG Oral TabletSCD4f5855b7-d3d4-3477-e054-00144ff8d46c1
866094buspirone hydrochloride 5 MG Oral TabletSCD8b6e7ae6-5b83-4a5a-ab45-cf4be4287d781
866094buspirone hydrochloride 5 MG Oral TabletSCD8e85d869-fe78-3148-e053-2995a90a207c1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY4f5855b7-d3d4-3477-e054-00144ff8d46c1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8b6e7ae6-5b83-4a5a-ab45-cf4be4287d781
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8e85d869-fe78-3148-e053-2995a90a207c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-200-0116729020001100 TABLET in 1 BOTTLE (16729-200-01) 100 tablet2016-12-150000-00-00NoNoCurrent
16729-200-1616729020016500 TABLET in 1 BOTTLE (16729-200-16) 500 tablet2016-12-150000-00-00NoNoCurrent
16729-200-17167290200171000 TABLET in 1 BOTTLE (16729-200-17) 1000 tablet2020-01-010000-00-00NoNoCurrent