Buspirone Hydrochloride

Product NDC
68788-7952
11-digit product format
687887952
Labeler code
68788
Product ID
68788-7952_1c2ab390-7d01-4593-9e70-af3cddfbd754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210907
Marketing category
ANDA
Marketing start
2021-07-09
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866094

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
68788-7952-1Buspirone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1006
68788-7952-3Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET306
68788-7952-6Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET606
68788-7952-9Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7952-1EA - Each68788-7952d8e01613-6413-4e80-9aab-c4285aa9c91012021-08-05
68788-7952-3EA - Each68788-795213c4dde9-1004-4356-aec5-dd7a28401bb112021-08-05
68788-7952-6EA - Each68788-79522d6bbee3-fe15-4e9c-b0b1-2729b4660d3712021-08-05
68788-7952-9EA - Each68788-795225cad719-02d3-4b11-a768-2930f8660e5812021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7952BUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20250214_824c80e6-d508-405f-8a4f-2f10df5a9dc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN824c80e6-d508-405f-8a4f-2f10df5a9dc86
866094buspirone hydrochloride 5 MG Oral TabletSCD824c80e6-d508-405f-8a4f-2f10df5a9dc86
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY824c80e6-d508-405f-8a4f-2f10df5a9dc86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7952-168788795201100 TABLET in 1 BOTTLE, PLASTIC (68788-7952-1) 100 tablet2021-07-090000-00-00NoNoCurrent
68788-7952-36878879520330 TABLET in 1 BOTTLE, PLASTIC (68788-7952-3) 30 tablet2021-07-090000-00-00NoNoCurrent
68788-7952-66878879520660 TABLET in 1 BOTTLE, PLASTIC (68788-7952-6) 60 tablet2021-07-090000-00-00NoNoCurrent
68788-7952-96878879520990 TABLET in 1 BOTTLE, PLASTIC (68788-7952-9) 90 tablet2021-07-090000-00-00NoNoCurrent