Risperidone

Product NDC
13668-040
11-digit product format
136680040
Labeler code
13668
Product ID
13668-040_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
4 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
RISPERIDONE4 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
13668-040-01Risperidone100 in 1 BOTTLETABLET10025
13668-040-05Risperidone500 in 1 BOTTLETABLET50025
13668-040-57Risperidone2100 in 1 BOTTLETABLET210025
13668-040-60Risperidone60 in 1 BOTTLETABLET6025
13668-040-64Risperidone90 in 1 CARTONTABLET9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-040-01EA - Each13668-040e3045e05-c231-431b-97de-0813b443381f12012-07-24
13668-040-05EA - Each13668-040e2864cf1-b320-44bf-9587-3ab5e1fe554d12012-07-24
13668-040-60EA - Each13668-0401ba81791-0790-4212-be86-de1873d7e96212012-07-24
13668-040-64EA - Each13668-0409ccf8a3c-69dd-4d62-aa3f-ccb096e062c312012-07-24

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 [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-040RISPERIDONE 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
312830risperiDONE 1 MG Oral TabletPSNdce4437a-bf43-483c-8db2-5eb58fa8a5591
312831risperiDONE 2 MG Oral TabletPSNdce4437a-bf43-483c-8db2-5eb58fa8a5591
312832risperiDONE 3 MG Oral TabletPSNdce4437a-bf43-483c-8db2-5eb58fa8a5591
314211risperiDONE 4 MG Oral TabletPSNdce4437a-bf43-483c-8db2-5eb58fa8a5591
312830risperidone 1 MG Oral TabletSCDdce4437a-bf43-483c-8db2-5eb58fa8a5591
312831risperidone 2 MG Oral TabletSCDdce4437a-bf43-483c-8db2-5eb58fa8a5591
312832risperidone 3 MG Oral TabletSCDdce4437a-bf43-483c-8db2-5eb58fa8a5591
314211risperidone 4 MG Oral TabletSCDdce4437a-bf43-483c-8db2-5eb58fa8a5591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-040-0113668004001100 TABLET in 1 BOTTLE (13668-040-01) 100 tablet2009-01-010000-00-00NoNoCurrent
13668-040-0513668004005500 TABLET in 1 BOTTLE (13668-040-05) 500 tablet2009-01-010000-00-00NoNoCurrent
13668-040-57136680040572100 TABLET in 1 BOTTLE (13668-040-57) 2100 tablet2009-01-010000-00-00NoNoCurrent
13668-040-601366800406060 TABLET in 1 BOTTLE (13668-040-60) 60 tablet2009-01-010000-00-00NoNoCurrent
13668-040-641366800406490 TABLET in 1 CARTON (13668-040-64) 90 tablet2009-01-010000-00-00NoNoCurrent