FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
76420-724
11-digit product format
764200724
Labeler code
76420
Product ID
76420-724_5100f189-0915-07b9-e063-6394a90acd18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-10-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2027-12-31

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
76420-724-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1002
76420-724-05Buspirone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5002
76420-724-12Buspirone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
76420-724-18Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1802
76420-724-30Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
76420-724-60Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
76420-724-90Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-724BUSPIRONE HYDROCHLORIDE TABLET [ASCLEMED USA, INC.]1Current NDC, 7 package rows20240512_97f2d082-0931-4e4f-a5be-7792e399e42b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866018busPIRone HCl 15 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866090busPIRone HCl 30 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866094busPIRone HCl 5 MG Oral TabletPSN97f2d082-0931-4e4f-a5be-7792e399e42b2
866083buspirone hydrochloride 10 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866018buspirone hydrochloride 15 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866090buspirone hydrochloride 30 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866094buspirone hydrochloride 5 MG Oral TabletSCD97f2d082-0931-4e4f-a5be-7792e399e42b2
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-724-0176420072401100 TABLET in 1 BOTTLE, PLASTIC (76420-724-01) 100 tablet2024-05-06NoNoHistorical
76420-724-0576420072405500 TABLET in 1 BOTTLE, PLASTIC (76420-724-05) 500 tablet2024-05-06NoNoHistorical
76420-724-1276420072412120 TABLET in 1 BOTTLE, PLASTIC (76420-724-12) 120 tablet2026-05-04NoNoHistorical
76420-724-1876420072418180 TABLET in 1 BOTTLE, PLASTIC (76420-724-18) 180 tablet2024-05-06NoNoHistorical
76420-724-307642007243030 TABLET in 1 BOTTLE, PLASTIC (76420-724-30) 30 tablet2024-05-06NoNoHistorical
76420-724-607642007246060 TABLET in 1 BOTTLE, PLASTIC (76420-724-60) 60 tablet2024-05-06NoNoHistorical
76420-724-907642007249090 TABLET in 1 BOTTLE, PLASTIC (76420-724-90) 90 tablet2024-05-06NoNoHistorical