Buspirone Hydrochloride

Product NDC
68071-3989
11-digit product format
680713989
Labeler code
68071
Product ID
68071-3989_50b17bc4-8d75-58f2-e063-6294a90a4618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202330
Marketing category
ANDA
Marketing start
2015-06-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083

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
68071-3989-6Buspirone Hydrochloride60 in 1 BOTTLETABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN50b18368-d37c-374b-e063-6394a90a81141
866083buspirone hydrochloride 10 MG Oral TabletSCD50b18368-d37c-374b-e063-6394a90a81141
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY50b18368-d37c-374b-e063-6394a90a81141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3989-66807139890660 TABLET in 1 BOTTLE (68071-3989-6) 60 tablet2026-04-30NoNoCurrent