FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
29300-478
11-digit product format
293000478
Labeler code
29300
Product ID
29300-478_ef78a61a-865b-447a-9324-3044e41db506
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2023-10-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 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
29300-478-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007
29300-478-05Buspirone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5007
29300-478-16Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-478BUSPIRONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7Current NDC, 3 package rows20231223_a6bdf140-075e-445e-a62d-633a4b97f3a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866090busPIRone HCl 30 MG Oral TabletPSN48b4e52d-d4c4-4d24-a0ac-24316371cef09
866090buspirone hydrochloride 30 MG Oral TabletSCD48b4e52d-d4c4-4d24-a0ac-24316371cef09
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY48b4e52d-d4c4-4d24-a0ac-24316371cef09
866083busPIRone HCl 10 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866018busPIRone HCl 15 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866090busPIRone HCl 30 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866094busPIRone HCl 5 MG Oral TabletPSNa6bdf140-075e-445e-a62d-633a4b97f3a87
866083buspirone hydrochloride 10 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866018buspirone hydrochloride 15 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866090buspirone hydrochloride 30 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866094buspirone hydrochloride 5 MG Oral TabletSCDa6bdf140-075e-445e-a62d-633a4b97f3a87
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYa6bdf140-075e-445e-a62d-633a4b97f3a87
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
866090busPIRone HCl 30 MG Oral TabletPSNed2b56fe-e02f-46bc-808a-352f9bbb5b572
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 TabletSCDed2b56fe-e02f-46bc-808a-352f9bbb5b572
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
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYed2b56fe-e02f-46bc-808a-352f9bbb5b572
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY97f2d082-0931-4e4f-a5be-7792e399e42b2
866090busPIRone HCl 30 MG Oral TabletPSN38faa7cb-d858-4481-8649-35d228acbd381
866090busPIRone HCl 30 MG Oral TabletPSN26a5943c-1250-74d0-e063-6394a90ac6461
866090busPIRone HCl 30 MG Oral TabletPSN1e1b68d1-40ac-a627-e063-6394a90ac1671
866090buspirone hydrochloride 30 MG Oral TabletSCD1e1b68d1-40ac-a627-e063-6394a90ac1671
866090buspirone hydrochloride 30 MG Oral TabletSCD38faa7cb-d858-4481-8649-35d228acbd381
866090buspirone hydrochloride 30 MG Oral TabletSCD26a5943c-1250-74d0-e063-6394a90ac6461
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY38faa7cb-d858-4481-8649-35d228acbd381
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY26a5943c-1250-74d0-e063-6394a90ac6461
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSY1e1b68d1-40ac-a627-e063-6394a90ac1671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
29300-478-0129300047801100 TABLET in 1 BOTTLE, PLASTIC (29300-478-01) 100 tablet2023-12-22NoNoCurrent
29300-478-0529300047805500 TABLET in 1 BOTTLE, PLASTIC (29300-478-05) 500 tablet2023-12-22NoNoCurrent
29300-478-162930004781660 TABLET in 1 BOTTLE, PLASTIC (29300-478-16) 60 tablet2023-12-22NoNoCurrent