FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
70518-2031
11-digit product format
705182031
Labeler code
70518
Product ID
70518-2031_499b44fe-d3dc-219a-e063-6294a90a0428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204582
Marketing category
ANDA
Marketing start
2019-04-18
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
70518-2031-0Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET3018
70518-2031-1Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET3018
70518-2031-2Buspirone Hydrochloride45 in 1 BOTTLE, PLASTICTABLET4518
70518-2031-3Buspirone Hydrochloride60 in 1 BLISTER PACKTABLET6018
70518-2031-4Buspirone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6018
70518-2031-5Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2031BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 6 package rows20250306_a9fc7091-b3ce-45fd-8d89-aeebdd81c327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNa9fc7091-b3ce-45fd-8d89-aeebdd81c32718
866083buspirone hydrochloride 10 MG Oral TabletSCDa9fc7091-b3ce-45fd-8d89-aeebdd81c32718
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYa9fc7091-b3ce-45fd-8d89-aeebdd81c32718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2031-07051820310030 TABLET in 1 BLISTER PACK (70518-2031-0) 30 tablet2019-04-180000-00-00NoNoCurrent
70518-2031-17051820310130 TABLET in 1 BLISTER PACK (70518-2031-1) 30 tablet2020-05-190000-00-00NoNoCurrent
70518-2031-27051820310245 TABLET in 1 BOTTLE, PLASTIC (70518-2031-2) 45 tablet2020-07-280000-00-00NoNoCurrent
70518-2031-37051820310360 TABLET in 1 BLISTER PACK (70518-2031-3) 60 tablet2023-01-050000-00-00NoNoCurrent
70518-2031-47051820310460 TABLET in 1 BOTTLE, PLASTIC (70518-2031-4) 60 tablet2025-06-18NoNoCurrent
70518-2031-57051820310590 TABLET in 1 BOTTLE, PLASTIC (70518-2031-5) 90 tablet2025-06-30NoNoCurrent