FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
60687-801
11-digit product format
606870801
Labeler code
60687
Product ID
60687-801_1a4e0770-e1ad-f44a-e063-6294a90a8257
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078888
Marketing category
ANDA
Marketing start
2024-02-21
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866111

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
60687-801-11Buspirone hydrochloride1 in 1 BLISTER PACKTABLET13
60687-801-21Buspirone hydrochloride30 in 1 CARTONTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-801-11EA - Each60687-8018e47c11e-92f2-4671-b389-c594240df49a12024-02-14
60687-801-21EA - Each60687-801e98fba47-bb54-4c7b-b434-df4419d028dc12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-801BUSPIRONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3Current NDC, 2 package rows20240618_e80d83a6-7c2a-478e-bdf1-c481824fc301.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNe80d83a6-7c2a-478e-bdf1-c481824fc3013
866018busPIRone HCl 15 MG Oral TabletPSNe80d83a6-7c2a-478e-bdf1-c481824fc3013
866111busPIRone HCl 7.5 MG Oral TabletPSNe80d83a6-7c2a-478e-bdf1-c481824fc3013
866083buspirone hydrochloride 10 MG Oral TabletSCDe80d83a6-7c2a-478e-bdf1-c481824fc3013
866018buspirone hydrochloride 15 MG Oral TabletSCDe80d83a6-7c2a-478e-bdf1-c481824fc3013
866111buspirone hydrochloride 7.5 MG Oral TabletSCDe80d83a6-7c2a-478e-bdf1-c481824fc3013
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYe80d83a6-7c2a-478e-bdf1-c481824fc3013
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYe80d83a6-7c2a-478e-bdf1-c481824fc3013
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYe80d83a6-7c2a-478e-bdf1-c481824fc3013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-801-11606870801111 in 1 BLISTER PACKHistorical
60687-801-216068708012130 BLISTER PACK in 1 CARTON (60687-801-21) / 1 TABLET in 1 BLISTER PACK (60687-801-11) 30 blister pack2024-02-21NoNoHistorical