FDA.reportPublic FDA data

Buspirone hydrochloride

Product NDC
69117-0041
11-digit product format
691170041
Labeler code
69117
Product ID
69117-0041_f16635a5-7e1a-534a-e053-2995a90a9355
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA202087
Marketing category
ANDA
Marketing start
2019-10-30
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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
69117-0041-12025-01-30C16284748780-12cef2736-66a8-d83d-e063-dadaa90ab31fBUSPIRONE HYDROCHLORIDE TABLETS, USP (Patient Instruction Sheet Included) Rx only
69117-0041-22025-01-30C16284748780-12cef2736-66a8-d83d-e063-dadaa90ab31fBUSPIRONE HYDROCHLORIDE TABLETS, USP (Patient Instruction Sheet Included) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69117-0041-1Buspirone hydrochloride100 in 1 BOTTLETABLET1004
69117-0041-2Buspirone hydrochloride500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0041-1EA - Each69117-004197512e9a-7d99-4451-a36f-7f6db7e1658212020-04-20
69117-0041-2EA - Each69117-00417e1f0c84-2360-480d-8c1f-5e8fca2009a112020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0041BUSPIRONE HYDROCHLORIDE TABLET [YILING PHARMACEUTICAL, INC.]4Legacy NDC, 2 package rows20230105_ff9cd082-e9e0-4f89-8b0f-8cbb20941408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNff9cd082-e9e0-4f89-8b0f-8cbb209414084
866018busPIRone HCl 15 MG Oral TabletPSNff9cd082-e9e0-4f89-8b0f-8cbb209414084
866090busPIRone HCl 30 MG Oral TabletPSNff9cd082-e9e0-4f89-8b0f-8cbb209414084
866094busPIRone HCl 5 MG Oral TabletPSNff9cd082-e9e0-4f89-8b0f-8cbb209414084
866083buspirone hydrochloride 10 MG Oral TabletSCDff9cd082-e9e0-4f89-8b0f-8cbb209414084
866018buspirone hydrochloride 15 MG Oral TabletSCDff9cd082-e9e0-4f89-8b0f-8cbb209414084
866090buspirone hydrochloride 30 MG Oral TabletSCDff9cd082-e9e0-4f89-8b0f-8cbb209414084
866094buspirone hydrochloride 5 MG Oral TabletSCDff9cd082-e9e0-4f89-8b0f-8cbb209414084
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYff9cd082-e9e0-4f89-8b0f-8cbb209414084
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYff9cd082-e9e0-4f89-8b0f-8cbb209414084
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYff9cd082-e9e0-4f89-8b0f-8cbb209414084
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYff9cd082-e9e0-4f89-8b0f-8cbb209414084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-0041-169117004101100 TABLET in 1 BOTTLE (69117-0041-1) 100 tablet2019-10-300000-00-00NoNoCurrent
69117-0041-269117004102500 TABLET in 1 BOTTLE (69117-0041-2) 500 tablet2019-10-300000-00-00NoNoCurrent