FDA.reportPublic FDA data

BUSPIRONE HYDROCHLORIDE

Product NDC
61919-166
11-digit product format
619190166
Labeler code
61919
Product ID
61919-166_47e15246-5edb-3524-e063-6294a90a3fd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSPIRONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA202557
Marketing category
ANDA
Marketing start
2019-07-26
Substance
BUSPIRONE HYDROCHLORIDE
Active strength
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207LT9J9OC
Rxcui866094

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
61919-166-302021-01-29C16284748780-1ba0f9c33-45b7-a910-e053-dadaa90a0b85BUSPIRONE
61919-166-902020-01-31C16284748780-19d75b9d0-d9c3-f424-e053-dadaa90a57ceBUSPIRONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-166-60BUSPIRONE HYDROCHLORIDE60 in 1 BOTTLETABLET605
61919-166-30BUSPIRONE HYDROCHLORIDE30 in 1 BOTTLETABLET301
61919-166-90BUSPIRONE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-166-30EA - Each61919-1660be21527-734d-43ff-aa03-f1947a01b4af12019-09-05
61919-166-60EA - Each61919-1669b6ec070-3e50-4928-bee2-5aa55f12b4c512019-09-05
61919-166-90EA - Each61919-166145fabb3-4974-490f-ba8c-973c80b064fa12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-166BUSPIRONE HYDROCHLORIDE TABLET [DIRECT_RX]4Current NDC, Legacy NDC, 1 package rows20240110_8e9c0553-c994-f54a-e053-2a95a90a6fa3.zip
61919-166BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]1Current NDC, Legacy NDC, 1 package rows20170512_4f5855b7-d3d4-3477-e054-00144ff8d46c.zip
61919-166BUSPIRONE HYDROCHLORIDE TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190726_8e85d869-fe78-3148-e053-2995a90a207c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866094busPIRone HCl 5 MG Oral TabletPSN8e9c0553-c994-f54a-e053-2a95a90a6fa35
866094buspirone hydrochloride 5 MG Oral TabletSCD8e9c0553-c994-f54a-e053-2a95a90a6fa35
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8e9c0553-c994-f54a-e053-2a95a90a6fa35
866094busPIRone HCl 5 MG Oral TabletPSN4f5855b7-d3d4-3477-e054-00144ff8d46c1
866094busPIRone HCl 5 MG Oral TabletPSN8e85d869-fe78-3148-e053-2995a90a207c1
866094buspirone hydrochloride 5 MG Oral TabletSCD4f5855b7-d3d4-3477-e054-00144ff8d46c1
866094buspirone hydrochloride 5 MG Oral TabletSCD8e85d869-fe78-3148-e053-2995a90a207c1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY4f5855b7-d3d4-3477-e054-00144ff8d46c1
866094buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral TabletSY8e85d869-fe78-3148-e053-2995a90a207c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-166-306191901663030 in 1 BOTTLEHistorical
61919-166-606191901666060 TABLET in 1 BOTTLE (61919-166-60) 60 tablet2019-07-260000-00-00NoNoCurrent
61919-166-906191901669090 in 1 BOTTLEHistorical