FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
75834-266
11-digit product format
758340266
Labeler code
75834
Product ID
75834-266_5bad7053-8f63-45fc-adb0-88c628fa039b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals Inc.
Application
ANDA209696
Marketing category
ANDA
Marketing start
2021-02-15
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
Rxcui866018, 866083, 866090, 866094, 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
75834-266-01Buspirone Hydrochloride100 in 1 BOTTLETABLET1001
75834-266-05Buspirone Hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-266-01EA - Each75834-266f134d9f4-0bff-4ac9-a6ab-acace240cff712021-04-08
75834-266-05EA - Each75834-26664c31407-7b38-4c49-b15d-508b9a87a22112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-266BUSPIRONE HYDROCHLORIDE TABLET [NIVAGEN PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20210227_b08dd2e7-e808-4b51-b404-5009076b82eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNb08dd2e7-e808-4b51-b404-5009076b82eb1
866018busPIRone HCl 15 MG Oral TabletPSNb08dd2e7-e808-4b51-b404-5009076b82eb1
866090busPIRone HCl 30 MG Oral TabletPSNb08dd2e7-e808-4b51-b404-5009076b82eb1
866094busPIRone HCl 5 MG Oral TabletPSNb08dd2e7-e808-4b51-b404-5009076b82eb1
866111busPIRone HCl 7.5 MG Oral TabletPSNb08dd2e7-e808-4b51-b404-5009076b82eb1
866083buspirone hydrochloride 10 MG Oral TabletSCDb08dd2e7-e808-4b51-b404-5009076b82eb1
866018buspirone hydrochloride 15 MG Oral TabletSCDb08dd2e7-e808-4b51-b404-5009076b82eb1
866090buspirone hydrochloride 30 MG Oral TabletSCDb08dd2e7-e808-4b51-b404-5009076b82eb1
866094buspirone hydrochloride 5 MG Oral TabletSCDb08dd2e7-e808-4b51-b404-5009076b82eb1
866111buspirone hydrochloride 7.5 MG Oral TabletSCDb08dd2e7-e808-4b51-b404-5009076b82eb1
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYb08dd2e7-e808-4b51-b404-5009076b82eb1
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYb08dd2e7-e808-4b51-b404-5009076b82eb1
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYb08dd2e7-e808-4b51-b404-5009076b82eb1
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYb08dd2e7-e808-4b51-b404-5009076b82eb1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYb08dd2e7-e808-4b51-b404-5009076b82eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-266-0175834026601100 TABLET in 1 BOTTLE (75834-266-01) 100 tablet2021-02-150000-00-00NoNoCurrent
75834-266-0575834026605500 TABLET in 1 BOTTLE (75834-266-05) 500 tablet2021-02-150000-00-00NoNoCurrent