Buspirone Hydrochloride

Product NDC
50090-5347
11-digit product format
500905347
Labeler code
50090
Product ID
50090-5347_0676094b-d9ed-4859-a0b6-251a1219840e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202330
Marketing category
ANDA
Marketing start
2015-06-30
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866083

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5347-02023-02-06C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-12023-02-06C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-32023-02-06C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-42023-02-06C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-52023-02-06C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-02023-01-30C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-12023-01-30C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-32023-01-30C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-42023-01-30C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)
50090-5347-52023-01-30C16284748780-1f386c64a-1762-0266-e053-dadaa90a7c1aBuspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5347-0Buspirone Hydrochloride30 in 1 BOTTLETABLET306
50090-5347-1Buspirone Hydrochloride90 in 1 BOTTLETABLET906
50090-5347-3Buspirone Hydrochloride180 in 1 BOTTLETABLET1806
50090-5347-4Buspirone Hydrochloride45 in 1 BOTTLETABLET456
50090-5347-5Buspirone Hydrochloride60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5347-0EA - Each50090-534700513c01-505e-4504-9a32-3438ec7d200e12026-02-05
50090-5347-1EA - Each50090-5347c4c1db7d-3350-43fe-956e-01b63df98e7a12023-02-06
50090-5347-3EA - Each50090-534742ccaa4e-67cf-4553-8749-28d28e90cc1d12026-02-05
50090-5347-4EA - Each50090-53470dc42a50-73f9-4782-95d3-a78ab9b82b4112026-02-05
50090-5347-5EA - Each50090-5347b7a5dd49-5280-477c-8721-ada7110bcfd812026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNecdfd79e-7450-40ec-9561-cdda3a0439906
866083buspirone hydrochloride 10 MG Oral TabletSCDecdfd79e-7450-40ec-9561-cdda3a0439906
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYecdfd79e-7450-40ec-9561-cdda3a0439906

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5347-05009053470030 TABLET in 1 BOTTLE (50090-5347-0) 30 tablet2020-11-090000-00-00NoNoCurrent
50090-5347-15009053470190 TABLET in 1 BOTTLE (50090-5347-1) 90 tablet2020-11-090000-00-00NoNoCurrent
50090-5347-350090534703180 TABLET in 1 BOTTLE (50090-5347-3) 180 tablet2020-11-090000-00-00NoNoCurrent
50090-5347-45009053470445 TABLET in 1 BOTTLE (50090-5347-4) 45 tablet2020-11-090000-00-00NoNoCurrent
50090-5347-55009053470560 TABLET in 1 BOTTLE (50090-5347-5) 60 tablet2020-11-090000-00-00NoNoCurrent