FDA.reportPublic FDA data

RISPERDAL

Product NDC
21695-113
11-digit product format
216950113
Labeler code
21695
Product ID
21695-113_fca1c3cd-45f3-45cc-bb1d-656c65e91c8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020272
Marketing category
NDA
Marketing start
1993-12-29
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-113-152019-09-24C16284748780-1934fe258-4c47-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use RISPERDAL ® safely and effectively. See full prescribing information for RISPERDAL ® . RISPERDAL ® (risperidone) tablets, RISPERDAL® (risperidone) oral solution, RISPERDAL ® M-TAB ® (risperidone) orally disintegrating tablets Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-113-15RISPERDAL15 in 1 BOTTLETABLET152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-113-15EA - Each21695-11327b5d6e6-6a7e-48b5-8333-87799d0ae22412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
risperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
risperidoneACTIVE MOIETYL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKRISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GRISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
magnesium stearateINACTIVE INGREDIENT70097M6I30RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JRISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
starch, cornINACTIVE INGREDIENTO8232NY3SJRISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
talcINACTIVE INGREDIENT7SEV7J4R1URISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-113RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 1 package rows20110815_01859e07-1262-4cc6-b7ed-5a273cbf0c36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104781RisperDAL 1 MG Oral TabletPSN01859e07-1262-4cc6-b7ed-5a273cbf0c362
104783RisperDAL 3 MG Oral TabletPSN01859e07-1262-4cc6-b7ed-5a273cbf0c362
312830risperiDONE 1 MG Oral TabletPSN01859e07-1262-4cc6-b7ed-5a273cbf0c362
312832risperiDONE 3 MG Oral TabletPSN01859e07-1262-4cc6-b7ed-5a273cbf0c362
104781risperidone 1 MG Oral Tablet [Risperdal]SBD01859e07-1262-4cc6-b7ed-5a273cbf0c362
104783risperidone 3 MG Oral Tablet [Risperdal]SBD01859e07-1262-4cc6-b7ed-5a273cbf0c362
312830risperidone 1 MG Oral TabletSCD01859e07-1262-4cc6-b7ed-5a273cbf0c362
312832risperidone 3 MG Oral TabletSCD01859e07-1262-4cc6-b7ed-5a273cbf0c362
104781Risperdal 1 MG Oral TabletSY01859e07-1262-4cc6-b7ed-5a273cbf0c362
104783Risperdal 3 MG Oral TabletSY01859e07-1262-4cc6-b7ed-5a273cbf0c362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-113-152169501131515 in 1 BOTTLEHistorical