FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
51407-414
11-digit product format
514070414
Labeler code
51407
Product ID
51407-414_4b1f20ca-5708-e1f4-e063-6294a90ac5dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA202330
Marketing category
ANDA
Marketing start
2017-02-17
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 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
51407-414-01Buspirone Hydrochloride100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-414-01EA - Each51407-414032b44a3-7ba2-4298-a952-2bb1a579da3a12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-414BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, Legacy NDC, 1 package rows20240823_bcce49d3-c8eb-9f9b-e053-2995a90a67d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866018busPIRone HCl 15 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866090busPIRone HCl 30 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866094busPIRone HCl 5 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866111busPIRone HCl 7.5 MG Oral TabletPSNbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866083buspirone hydrochloride 10 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866018buspirone hydrochloride 15 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866090buspirone hydrochloride 30 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866094buspirone hydrochloride 5 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866111buspirone hydrochloride 7.5 MG Oral TabletSCDbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYbcce49d3-c8eb-9f9b-e053-2995a90a67d96
866111busPIRone HCl 7.5 MG Oral TabletPSN62e4345a-2c51-4f93-89f0-282895ced7851
866111buspirone hydrochloride 7.5 MG Oral TabletSCD62e4345a-2c51-4f93-89f0-282895ced7851
866111buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral TabletSY62e4345a-2c51-4f93-89f0-282895ced7851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-414-0151407041401100 TABLET in 1 BOTTLE (51407-414-01) 100 tablet2021-04-010000-00-00NoNoCurrent