FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
48433-014
11-digit product format
484330014
Labeler code
48433
Product ID
48433-014_4b433e49-a0b8-2f27-e063-6294a90af1b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA076008
Marketing category
ANDA
Marketing start
2026-02-04
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866018, 866083, 866090, 866094

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
48433-014-01Buspirone Hydrochloride1 in 1 BLISTER PACKTABLET13
48433-014-20Buspirone Hydrochloride100 in 1 CARTONTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-014-20EA - Each48433-01449aacc6e-fca1-4d2c-b4dc-21296d0716bc12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866018busPIRone HCl 15 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866090busPIRone HCl 30 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866094busPIRone HCl 5 MG Oral TabletPSNebda05ee-d895-4636-bc28-d393e69c91b33
866083buspirone hydrochloride 10 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866018buspirone hydrochloride 15 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866090buspirone hydrochloride 30 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866094buspirone hydrochloride 5 MG Oral TabletSCDebda05ee-d895-4636-bc28-d393e69c91b33
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYebda05ee-d895-4636-bc28-d393e69c91b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-014-01484330014011 in 1 BLISTER PACKHistorical
48433-014-2048433001420100 BLISTER PACK in 1 CARTON (48433-014-20) / 1 TABLET in 1 BLISTER PACK (48433-014-01) 100 blister pack2026-02-04NoNoCurrent