FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
29300-477
11-digit product format
293000477
Labeler code
29300
Product ID
29300-477_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
15 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 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
29300-477-01Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007
29300-477-05Buspirone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5007
29300-477-16Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET607
29300-477-18Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-477BUSPIRONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7Current NDC, 4 package rows20231223_a6bdf140-075e-445e-a62d-633a4b97f3a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
866018busPIRone HCl 15 MG Oral TabletPSN2a25a718-306f-403e-9928-cae30bc52f126
866018busPIRone HCl 15 MG Oral TabletPSNfbff8248-b73c-474e-907e-449f8316c6296
866018buspirone hydrochloride 15 MG Oral TabletSCDfbff8248-b73c-474e-907e-449f8316c6296
866018buspirone hydrochloride 15 MG Oral TabletSCD2a25a718-306f-403e-9928-cae30bc52f126
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY2a25a718-306f-403e-9928-cae30bc52f126
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYfbff8248-b73c-474e-907e-449f8316c6296
866018busPIRone HCl 15 MG Oral TabletPSN3246dd4d-f787-2f62-e063-6294a90a9cd24
866018buspirone hydrochloride 15 MG Oral TabletSCD3246dd4d-f787-2f62-e063-6294a90a9cd24
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY3246dd4d-f787-2f62-e063-6294a90a9cd24
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
866018busPIRone HCl 15 MG Oral TabletPSN19afb386-72a5-c97e-e063-6294a90adaea1
866018busPIRone HCl 15 MG Oral TabletPSN20866697-58cd-4639-ae21-2fff486aec811
866018busPIRone HCl 15 MG Oral TabletPSN26a64fbf-cca9-7105-e063-6394a90a968e1
866018busPIRone HCl 15 MG Oral TabletPSN335107c9-5799-c4df-e063-6294a90a5ca01
866018buspirone hydrochloride 15 MG Oral TabletSCD26a64fbf-cca9-7105-e063-6394a90a968e1
866018buspirone hydrochloride 15 MG Oral TabletSCD335107c9-5799-c4df-e063-6294a90a5ca01
866018buspirone hydrochloride 15 MG Oral TabletSCD20866697-58cd-4639-ae21-2fff486aec811
866018buspirone hydrochloride 15 MG Oral TabletSCD19afb386-72a5-c97e-e063-6294a90adaea1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY335107c9-5799-c4df-e063-6294a90a5ca01
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY26a64fbf-cca9-7105-e063-6394a90a968e1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY20866697-58cd-4639-ae21-2fff486aec811
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY19afb386-72a5-c97e-e063-6294a90adaea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
29300-477-0129300047701100 TABLET in 1 BOTTLE, PLASTIC (29300-477-01) 100 tablet2023-12-22NoNoCurrent
29300-477-0529300047705500 TABLET in 1 BOTTLE, PLASTIC (29300-477-05) 500 tablet2023-12-22NoNoCurrent
29300-477-162930004771660 TABLET in 1 BOTTLE, PLASTIC (29300-477-16) 60 tablet2023-12-22NoNoCurrent
29300-477-1829300047718180 TABLET in 1 BOTTLE, PLASTIC (29300-477-18) 180 tablet2023-12-22NoNoCurrent