FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
51655-015
11-digit product format
516550015
Labeler code
51655
Product ID
51655-015_46ddaa45-1fdf-f562-e063-6394a90ac7e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075022
Marketing category
ANDA
Marketing start
2015-02-25
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buspirone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSPIRONE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018

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
51655-015-522023-02-06C16284748780-19d75b9d0-8728-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets, USP Rx only
51655-015-522020-01-31C16284748780-19d75b9d0-8728-f424-e053-dadaa90a57ceBusPIRone Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-015-26Buspirone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET905
51655-015-52Buspirone Hydrochloride30 in 1 BOTTLE, DISPENSINGTABLET305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-015BUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240704_ff02c7cb-f96a-4a3b-99a2-812cd78b345c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866018busPIRone HCl 15 MG Oral TabletPSNff02c7cb-f96a-4a3b-99a2-812cd78b345c5
866018buspirone hydrochloride 15 MG Oral TabletSCDff02c7cb-f96a-4a3b-99a2-812cd78b345c5
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYff02c7cb-f96a-4a3b-99a2-812cd78b345c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-015-265165500152690 TABLET in 1 BOTTLE, PLASTIC (51655-015-26) 90 tablet2023-06-12NoNoCurrent
51655-015-525165500155230 TABLET in 1 BOTTLE, DISPENSING (51655-015-52) 30 tablet2015-02-25NoNoCurrent