FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
51655-097
11-digit product format
516550097
Labeler code
51655
Product ID
51655-097_46dddae4-4f92-3775-e063-6394a90a0432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204582
Marketing category
ANDA
Marketing start
2022-08-26
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
51655-097-26Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903
51655-097-52Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303
51655-097-83Buspirone Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-097BUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 3 package rows20240719_1d883a13-4877-c6c7-e063-6294a90a5137.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN1d883a13-4877-c6c7-e063-6294a90a51373
866083buspirone hydrochloride 10 MG Oral TabletSCD1d883a13-4877-c6c7-e063-6294a90a51373
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY1d883a13-4877-c6c7-e063-6294a90a51373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-097-265165500972690 TABLET in 1 BOTTLE, PLASTIC (51655-097-26) 90 tablet2022-08-26NoNoHistorical
51655-097-525165500975230 TABLET in 1 BOTTLE, PLASTIC (51655-097-52) 30 tablet2022-11-22NoNoHistorical
51655-097-8351655009783180 TABLET in 1 BOTTLE, PLASTIC (51655-097-83) 180 tablet2022-12-30NoNoHistorical