RISPERIDONE

Product NDC
61919-572
11-digit product format
619190572
Labeler code
61919
Product ID
61919-572_9cad1861-e8f9-0ee6-e053-2995a90aba73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078040
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6Product name520250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09eProduct name120250128
e457a910-2c3a-4bfd-90b9-0310982c50ddProduct name120241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-572-602023-01-30C16284748780-1f386c649-a11b-0266-e053-dadaa90a7c1aRISPERIDONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-572-60RISPERIDONE60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-572-60EA - Each61919-572f0113fd1-675a-4293-b4e5-4d4c25ecb00e12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-572RISPERIDONE TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20200130_89595dbd-2722-41f2-88ae-8c43769702bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSN89595dbd-2722-41f2-88ae-8c43769702bf3
312830risperidone 1 MG Oral TabletSCD89595dbd-2722-41f2-88ae-8c43769702bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-572-606191905726060 TABLET, FILM COATED in 1 BOTTLE (61919-572-60) 2014-01-010000-00-00NoNoCurrent