FDA.reportPublic FDA data

Risperidone

Product NDC
13668-035
11-digit product format
136680035
Labeler code
13668
Product ID
13668-035_cd8bfb14-7054-4c69-b27f-8a960b5ecb5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA079088
Marketing category
ANDA
Marketing start
2009-01-01
Substance
RISPERIDONE
Active strength
.25 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
RISPERIDONE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312828, 312829, 312830, 312831, 312832, 314211

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
13668-035-01Risperidone100 in 1 BOTTLETABLET10025
13668-035-05Risperidone500 in 1 BOTTLETABLET50025
13668-035-09Risperidone9990 in 1 BOTTLETABLET999025
13668-035-30Risperidone30 in 1 BOTTLETABLET3025
13668-035-60Risperidone60 in 1 BOTTLETABLET6025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-035-01EA - Each13668-03545aa5833-5008-4b85-b0b6-cd59a7e1f80812012-07-24
13668-035-05EA - Each13668-035f062fcf5-77b1-496b-ab6f-1d354a1e365012012-07-24
13668-035-60EA - Each13668-035c6e7eefa-dd87-4b6c-9214-9393c8a3ba7912012-07-24
13668-035-74EA - Each13668-0352eff22dc-aef3-4149-bb35-7411426e0b6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED]12
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED]12
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKRISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [PHYSICIANS TOTAL CARE, INC]5
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [REBEL DISTRIBUTORS CORP]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-035RISPERIDONE TABLET [TORRENT PHARMACEUTICALS LIMITED]24Current NDC, Legacy NDC, 5 package rows20250227_a6347895-5f16-43b4-92a0-b9904ac81937.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSNa6347895-5f16-43b4-92a0-b9904ac8193725
312829risperiDONE 0.5 MG Oral TabletPSNa6347895-5f16-43b4-92a0-b9904ac8193725
312830risperiDONE 1 MG Oral TabletPSNa6347895-5f16-43b4-92a0-b9904ac8193725
312831risperiDONE 2 MG Oral TabletPSNa6347895-5f16-43b4-92a0-b9904ac8193725
312832risperiDONE 3 MG Oral TabletPSNa6347895-5f16-43b4-92a0-b9904ac8193725
314211risperiDONE 4 MG Oral TabletPSNa6347895-5f16-43b4-92a0-b9904ac8193725
312828risperidone 0.25 MG Oral TabletSCDa6347895-5f16-43b4-92a0-b9904ac8193725
312829risperidone 0.5 MG Oral TabletSCDa6347895-5f16-43b4-92a0-b9904ac8193725
312830risperidone 1 MG Oral TabletSCDa6347895-5f16-43b4-92a0-b9904ac8193725
312831risperidone 2 MG Oral TabletSCDa6347895-5f16-43b4-92a0-b9904ac8193725
312832risperidone 3 MG Oral TabletSCDa6347895-5f16-43b4-92a0-b9904ac8193725
314211risperidone 4 MG Oral TabletSCDa6347895-5f16-43b4-92a0-b9904ac8193725
312828risperiDONE 0.25 MG Oral TabletPSNf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312829risperiDONE 0.5 MG Oral TabletPSNf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312830risperiDONE 1 MG Oral TabletPSNf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312831risperiDONE 2 MG Oral TabletPSNf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312828risperidone 0.25 MG Oral TabletSCDf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312829risperidone 0.5 MG Oral TabletSCDf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312830risperidone 1 MG Oral TabletSCDf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312831risperidone 2 MG Oral TabletSCDf0c765e9-edc1-4944-a4e6-91b82a29a8d75
312828risperiDONE 0.25 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312829risperiDONE 0.5 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312830risperiDONE 1 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312831risperiDONE 2 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312832risperiDONE 3 MG Oral TabletPSN2e8fb017-8754-421a-a76a-c41b8f48070b1
312828risperidone 0.25 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312829risperidone 0.5 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312830risperidone 1 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312831risperidone 2 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1
312832risperidone 3 MG Oral TabletSCD2e8fb017-8754-421a-a76a-c41b8f48070b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-035-0113668003501100 TABLET in 1 BOTTLE (13668-035-01) 100 tablet2009-01-010000-00-00NoNoCurrent
13668-035-0513668003505500 TABLET in 1 BOTTLE (13668-035-05) 500 tablet2009-01-010000-00-00NoNoCurrent
13668-035-09136680035099990 TABLET in 1 BOTTLE (13668-035-09) 9990 tablet2009-01-010000-00-00NoNoCurrent
13668-035-301366800353030 TABLET in 1 BOTTLE (13668-035-30) 30 tablet2009-01-010000-00-00NoNoCurrent
13668-035-601366800356060 TABLET in 1 BOTTLE (13668-035-60) 60 tablet2009-01-010000-00-00NoNoCurrent
13668-035-7413668003574100 TABLET in 1 CARTON (13668-035-74) 100 tablet2009-01-010000-00-00NoNoCurrent