Buspirone Hydrochloride

Product NDC
51655-796
11-digit product format
516550796
Labeler code
51655
Product ID
51655-796_4ba8aa52-6d36-c075-e063-6294a90a25a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA202330
Marketing category
ANDA
Marketing start
2022-02-18
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-796-262026-01-29C16284748780-149896155-afc4-586f-e063-e6dba90add90Buspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-796-26Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-796BUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20231219_d9de7cf1-c38d-8b3c-e053-2995a90aa26b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNd9de7cf1-c38d-8b3c-e053-2995a90aa26b4
866083buspirone hydrochloride 10 MG Oral TabletSCDd9de7cf1-c38d-8b3c-e053-2995a90aa26b4
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYd9de7cf1-c38d-8b3c-e053-2995a90aa26b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-796-265165507962690 TABLET in 1 BOTTLE, PLASTIC (51655-796-26) 90 tablet2022-02-180000-00-00NoNoCurrent