FDA.reportPublic FDA data

Risperidone

Product NDC
33261-849
11-digit product format
332610849
Labeler code
33261
Product ID
33261-849_dcae48af-ca48-4448-92b6-4ad661582bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA079088
Marketing category
ANDA
Marketing start
2009-01-01
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-849-302020-01-31C16284748780-19d75b9d0-fa93-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets, USP, for oral use Initial U.S. Approval: 1993
33261-849-602020-01-31C16284748780-19d75b9d0-fa93-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets, USP, for oral use Initial U.S. Approval: 1993
33261-849-902020-01-31C16284748780-19d75b9d0-fa93-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets, USP, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-849-30Risperidone30 in 1 BOTTLE, PLASTICTABLET301
33261-849-60Risperidone60 in 1 BOTTLE, PLASTICTABLET601
33261-849-90Risperidone90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-849-30EA - Each33261-849b2942503-e1a1-46d2-803f-42b18c890e5512015-10-02
33261-849-60EA - Each33261-849965ab303-1258-477e-8836-555bbe4fe2a212015-10-02
33261-849-90EA - Each33261-849e57601e6-23bb-4d30-8413-0791446667ed12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-849RISPERIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140213_c0a1be95-f691-4e0f-8d4e-ae7e26a00f1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSNc0a1be95-f691-4e0f-8d4e-ae7e26a00f1f1
312830risperidone 1 MG Oral TabletSCDc0a1be95-f691-4e0f-8d4e-ae7e26a00f1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-849-303326108493030 in 1 BOTTLE, PLASTICHistorical
33261-849-603326108496060 in 1 BOTTLE, PLASTICHistorical
33261-849-903326108499090 in 1 BOTTLE, PLASTICHistorical