Buspirone Hydrochloride

Product NDC
0904-7122
11-digit product format
009047122
Labeler code
0904
Product ID
0904-7122_7e3f9aeb-2fcc-4f4d-921b-a4b96a932d19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204582
Marketing category
ANDA
Marketing start
2012-06-29
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083, 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
0904-7122-61Buspirone Hydrochloride100 in 1 CARTONTABLET1004
0904-7122-61Buspirone Hydrochloride1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7122BUSPIRONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250210_8dc1ee33-e5aa-4462-8fb9-9bbdf5463488.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSN5424f933-93e1-4480-acdf-bd8667ae50e97
866094busPIRone HCl 5 MG Oral TabletPSN5424f933-93e1-4480-acdf-bd8667ae50e97
866083buspirone hydrochloride 10 MG Oral TabletSCD5424f933-93e1-4480-acdf-bd8667ae50e97
866094buspirone hydrochloride 5 MG Oral TabletSCD5424f933-93e1-4480-acdf-bd8667ae50e97
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY5424f933-93e1-4480-acdf-bd8667ae50e97
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY5424f933-93e1-4480-acdf-bd8667ae50e97
866083busPIRone HCl 10 MG Oral TabletPSN8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866094busPIRone HCl 5 MG Oral TabletPSN8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866083buspirone hydrochloride 10 MG Oral TabletSCD8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866094buspirone hydrochloride 5 MG Oral TabletSCD8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSY8dc1ee33-e5aa-4462-8fb9-9bbdf54634884
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8dc1ee33-e5aa-4462-8fb9-9bbdf54634884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7122-6100904712261100 BLISTER PACK in 1 CARTON (0904-7122-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2012-06-290000-00-00NoNoCurrent