Buspirone Hydrochloride

Product NDC
51655-511
11-digit product format
516550511
Labeler code
51655
Product ID
51655-511_4b47a2d1-9d96-fbd6-e063-6294a90a5fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA202557
Marketing category
ANDA
Marketing start
2022-12-20
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866111

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
51655-511-52Buspirone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-511BUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230316_f318ba7b-121f-2e4f-e053-2a95a90a60c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866111busPIRone HCl 7.5 MG Oral TabletPSNf318ba7b-121f-2e4f-e053-2a95a90a60c54
866111buspirone hydrochloride 7.5 MG Oral TabletSCDf318ba7b-121f-2e4f-e053-2a95a90a60c54
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYf318ba7b-121f-2e4f-e053-2a95a90a60c54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-511-525165505115230 TABLET in 1 BOTTLE, PLASTIC (51655-511-52) 30 tablet2022-12-20NoNoCurrent