Buspirone Hydrochloride

Product NDC
68788-7968
11-digit product format
687887968
Labeler code
68788
Product ID
68788-7968_ec86e8ce-c6a5-49bd-9196-55244b37ec30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2021-07-20
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

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
68788-7968-1Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1805
68788-7968-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET305
68788-7968-6Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET605
68788-7968-9Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7968BUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20240315_18ddef0b-1451-4bea-94fb-b6ec27f4744b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSN18ddef0b-1451-4bea-94fb-b6ec27f4744b5
866018buspirone hydrochloride 15 MG Oral TabletSCD18ddef0b-1451-4bea-94fb-b6ec27f4744b5
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSY18ddef0b-1451-4bea-94fb-b6ec27f4744b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7968-168788796801180 TABLET in 1 BOTTLE, PLASTIC (68788-7968-1) 180 tablet2021-07-200000-00-00NoNoCurrent
68788-7968-36878879680330 TABLET in 1 BOTTLE, PLASTIC (68788-7968-3) 30 tablet2021-07-200000-00-00NoNoCurrent
68788-7968-66878879680660 TABLET in 1 BOTTLE, PLASTIC (68788-7968-6) 60 tablet2021-07-200000-00-00NoNoCurrent
68788-7968-96878879680990 TABLET in 1 BOTTLE, PLASTIC (68788-7968-9) 90 tablet2021-07-200000-00-00NoNoCurrent