Buspirone Hydrochloride

Product NDC
68788-8086
11-digit product format
687888086
Labeler code
68788
Product ID
68788-8086_c98271e1-13bb-44a2-bdb1-22e6d682450c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2021-10-05
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
68788-8086-1Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1006
68788-8086-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET306
68788-8086-6Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET606
68788-8086-9Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8086-1EA - Each68788-8086031c2da3-30a4-4e20-a573-2325bbe157da12021-11-09
68788-8086-3EA - Each68788-80867660939e-1707-4160-aec5-1a70162dc4ed12021-11-09
68788-8086-6EA - Each68788-80863c901bc6-68c4-419e-85b7-c89ce3f78a9112021-11-09
68788-8086-9EA - Each68788-80862bbddc86-e9a2-464a-b5d8-fbeb9a29031512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8086BUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20250214_068ee1a0-a77a-4803-bad9-18117d7fb358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN068ee1a0-a77a-4803-bad9-18117d7fb3586
866083buspirone hydrochloride 10 MG Oral TabletSCD068ee1a0-a77a-4803-bad9-18117d7fb3586
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY068ee1a0-a77a-4803-bad9-18117d7fb3586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8086-168788808601100 TABLET in 1 BOTTLE, PLASTIC (68788-8086-1) 100 tablet2021-10-050000-00-00NoNoCurrent
68788-8086-36878880860330 TABLET in 1 BOTTLE, PLASTIC (68788-8086-3) 30 tablet2021-10-050000-00-00NoNoCurrent
68788-8086-66878880860660 TABLET in 1 BOTTLE, PLASTIC (68788-8086-6) 60 tablet2021-10-050000-00-00NoNoCurrent
68788-8086-96878880860990 TABLET in 1 BOTTLE, PLASTIC (68788-8086-9) 90 tablet2021-10-050000-00-00NoNoCurrent