Buspirone Hydrochloride

Product NDC
43063-785
11-digit product format
430630785
Labeler code
43063
Product ID
43063-785_4d5246b2-a725-6fc4-e063-6294a90a3219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx 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
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
43063-785-90Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-785-90EA - Each43063-7853d541dc9-a73e-4938-adf4-f3f28b432d3812017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-785BUSPIRONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 1 package rows20240820_7db10b76-4520-496e-b450-66a662cc95f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN7db10b76-4520-496e-b450-66a662cc95f620
866083buspirone hydrochloride 10 MG Oral TabletSCD7db10b76-4520-496e-b450-66a662cc95f620
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY7db10b76-4520-496e-b450-66a662cc95f620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-785-304306307853090 TABLET in 1 BOTTLE, PLASTIC (43063-785-30) 90 tablet2017-08-310000-00-00NoNoCurrent
43063-785-904306307859090 TABLET in 1 BOTTLE, PLASTIC (43063-785-90) 90 tablet2022-12-200000-00-00NoNoCurrent