Buspirone Hydrochloride

Product NDC
68071-3336
11-digit product format
680713336
Labeler code
68071
Product ID
68071-3336_1cd71696-d959-be3e-e063-6394a90a28c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202557
Marketing category
ANDA
Marketing start
2016-12-15
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3336-3Buspirone Hydrochloride30 in 1 BOTTLETABLET305
68071-3336-6Buspirone Hydrochloride60 in 1 BOTTLETABLET605
68071-3336-9Buspirone Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3336BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240711_540e9b7e-09ff-2cca-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN540e9b7e-09ff-2cca-e054-00144ff8d46c5
866083buspirone hydrochloride 10 MG Oral TabletSCD540e9b7e-09ff-2cca-e054-00144ff8d46c5
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY540e9b7e-09ff-2cca-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3336-36807133360330 TABLET in 1 BOTTLE (68071-3336-3) 30 tablet2017-07-110000-00-00NoNoCurrent
68071-3336-66807133360660 TABLET in 1 BOTTLE (68071-3336-6) 60 tablet2017-07-110000-00-00NoNoCurrent
68071-3336-96807133360990 TABLET in 1 BOTTLE (68071-3336-9) 90 tablet2017-07-110000-00-00NoNoCurrent