Buspirone Hydrochloride

Product NDC
67046-0645
11-digit product format
670460645
Labeler code
67046
Product ID
67046-0645_51011c43-fa9f-5b63-e063-6294a90a3793
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA210907
Marketing category
ANDA
Marketing start
2026-05-04
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866094

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
67046-0645-3Buspirone Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN510120d3-c922-a071-e063-6294a90af6a71
866094buspirone hydrochloride 5 MG Oral TabletSCD510120d3-c922-a071-e063-6294a90af6a71
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY510120d3-c922-a071-e063-6294a90af6a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0645-36704606450330 TABLET in 1 BLISTER PACK (67046-0645-3) 30 tablet2026-05-04NoNoHistorical