FDA.reportPublic FDA data

Risperidone

Product NDC
69292-574
11-digit product format
692920574
Labeler code
69292
Product ID
69292-574_616a890a-5d6d-448b-a6d0-24759f601731
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Amici Pharma, Inc.
Application
ANDA077328
Marketing category
ANDA
Marketing start
2026-04-01
Substance
RISPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Risperidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui401953, 401954, 403825, 616698, 616705

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69292-574-28Risperidone7 in 1 CARTONTABLET, ORALLY DISINTEGRATING71
69292-574-28Risperidone4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-574-28EA - Each69292-574dd5601aa-8b45-46c9-b16c-cea98b8e797d12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403825risperiDONE 0.5 MG Disintegrating Oral TabletPSNca41c144-224a-4d57-88d7-8778e6c69ed21
401953risperiDONE 1 MG Disintegrating Oral TabletPSNca41c144-224a-4d57-88d7-8778e6c69ed21
401954risperiDONE 2 MG Disintegrating Oral TabletPSNca41c144-224a-4d57-88d7-8778e6c69ed21
616698risperiDONE 3 MG Disintegrating Oral TabletPSNca41c144-224a-4d57-88d7-8778e6c69ed21
616705risperiDONE 4 MG Disintegrating Oral TabletPSNca41c144-224a-4d57-88d7-8778e6c69ed21
403825risperidone 0.5 MG Disintegrating Oral TabletSCDca41c144-224a-4d57-88d7-8778e6c69ed21
401953risperidone 1 MG Disintegrating Oral TabletSCDca41c144-224a-4d57-88d7-8778e6c69ed21
401954risperidone 2 MG Disintegrating Oral TabletSCDca41c144-224a-4d57-88d7-8778e6c69ed21
616698risperidone 3 MG Disintegrating Oral TabletSCDca41c144-224a-4d57-88d7-8778e6c69ed21
616705risperidone 4 MG Disintegrating Oral TabletSCDca41c144-224a-4d57-88d7-8778e6c69ed21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69292-574-28692920574287 BLISTER PACK in 1 CARTON (69292-574-28) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK7 blister pack2026-04-01NoNoHistorical