FDA.reportPublic FDA data

Buspirone Hydrochloride

Product NDC
55111-474
11-digit product format
551110474
Labeler code
55111
Product ID
55111-474_e4f9b1c3-d3ff-9ba2-9232-758efe2752d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buspirone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078246
Marketing category
ANDA
Marketing start
2009-03-04
Marketing end
0000-00-00
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
55111-474-012024-01-30C16284748780-11030e365-0c06-111a-e063-dadaa90a10e2Buspirone Hydrochloride
55111-474-052024-01-30C16284748780-11030e365-0c06-111a-e063-dadaa90a10e2Buspirone Hydrochloride
55111-474-182024-01-30C16284748780-11030e365-0c06-111a-e063-dadaa90a10e2Buspirone Hydrochloride
55111-474-302024-01-30C16284748780-11030e365-0c06-111a-e063-dadaa90a10e2Buspirone Hydrochloride
55111-474-602024-01-30C16284748780-11030e365-0c06-111a-e063-dadaa90a10e2Buspirone Hydrochloride
55111-474-782024-01-30C16284748780-11030e365-0c06-111a-e063-dadaa90a10e2Buspirone Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-474-01Buspirone Hydrochloride100 in 1 BOTTLETABLET1002
55111-474-05Buspirone Hydrochloride500 in 1 BOTTLETABLET5002
55111-474-18Buspirone Hydrochloride180 in 1 BOTTLETABLET1802
55111-474-30Buspirone Hydrochloride30 in 1 BOTTLETABLET302
55111-474-60Buspirone Hydrochloride60 in 1 BOTTLETABLET602
55111-474-78Buspirone Hydrochloride10 in 1 CARTONTABLET102
55111-474-79Buspirone Hydrochloride10 in 1 BLISTER PACKTABLET102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Buspirone HydrochlorideACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1
BuspironeACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1
magnesium stearateINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-474BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2Legacy NDC, 7 package rows20171204_c78cf4ff-51b2-851e-89cc-98ea543e3865.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866083busPIRone HCl 10 MG Oral TabletPSNc78cf4ff-51b2-851e-89cc-98ea543e38652
866018busPIRone HCl 15 MG Oral TabletPSNc78cf4ff-51b2-851e-89cc-98ea543e38652
866090busPIRone HCl 30 MG Oral TabletPSNc78cf4ff-51b2-851e-89cc-98ea543e38652
866094busPIRone HCl 5 MG Oral TabletPSNc78cf4ff-51b2-851e-89cc-98ea543e38652
866083buspirone hydrochloride 10 MG Oral TabletSCDc78cf4ff-51b2-851e-89cc-98ea543e38652
866018buspirone hydrochloride 15 MG Oral TabletSCDc78cf4ff-51b2-851e-89cc-98ea543e38652
866090buspirone hydrochloride 30 MG Oral TabletSCDc78cf4ff-51b2-851e-89cc-98ea543e38652
866094buspirone hydrochloride 5 MG Oral TabletSCDc78cf4ff-51b2-851e-89cc-98ea543e38652
866083buspirone HCl 10 MG (buspirone 9.1 MG) Oral TabletSYc78cf4ff-51b2-851e-89cc-98ea543e38652
866018buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral TabletSYc78cf4ff-51b2-851e-89cc-98ea543e38652
866090buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral TabletSYc78cf4ff-51b2-851e-89cc-98ea543e38652
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSYc78cf4ff-51b2-851e-89cc-98ea543e38652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-474-0155111047401100 TABLET in 1 BOTTLE (55111-474-01) 100 tablet2009-03-040000-00-00NoNoCurrent
55111-474-0555111047405500 TABLET in 1 BOTTLE (55111-474-05) 500 tablet2009-03-040000-00-00NoNoCurrent
55111-474-1855111047418180 TABLET in 1 BOTTLE (55111-474-18) 180 tablet2009-03-040000-00-00NoNoCurrent
55111-474-305511104743030 TABLET in 1 BOTTLE (55111-474-30) 30 tablet2009-03-040000-00-00NoNoCurrent
55111-474-605511104746060 TABLET in 1 BOTTLE (55111-474-60) 60 tablet2009-03-040000-00-00NoNoCurrent
55111-474-785511104747810 BLISTER PACK in 1 CARTON (55111-474-78) > 10 TABLET in 1 BLISTER PACK (55111-474-79) 10 blister pack2009-03-040000-00-00NoNoCurrent
55111-474-795511104747910 in 1 BLISTER PACKHistorical