risperidone

Product NDC
70748-271
11-digit product format
707480271
Labeler code
70748
Product ID
70748-271_295a5259-e2b6-4c5c-aacb-6a85a8c4babb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
KIT
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA211220
Marketing category
ANDA
Marketing start
2025-10-17
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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui402010, 402011, 402012

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-271-13risperidone1 in 1 BOXKIT14
70748-450-11risperidone2 mL in 1 VIALINJECTION, POWDER, FOR SUSPENSIO2 mL37.5 mg in 2mL4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402010risperiDONE 25 MG Extended Release InjectionPSNb462e48c-ef1d-4591-8fca-6b5829d8ed904
402011risperiDONE 37.5 MG Extended Release InjectionPSNb462e48c-ef1d-4591-8fca-6b5829d8ed904
402012risperiDONE 50 MG Extended Release InjectionPSNb462e48c-ef1d-4591-8fca-6b5829d8ed904
402010risperidone 25 MG InjectionSCDb462e48c-ef1d-4591-8fca-6b5829d8ed904
402011risperidone 37.5 MG InjectionSCDb462e48c-ef1d-4591-8fca-6b5829d8ed904
402012risperidone 50 MG InjectionSCDb462e48c-ef1d-4591-8fca-6b5829d8ed904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-271-13707480271131 KIT in 1 BOX (70748-271-13) * 2 mL in 1 VIAL (70748-450-11) * 2 mL in 1 SYRINGE (70748-448-01) 1 kit2025-10-17NoNoCurrent
70748-450-11707480450112 mL in 1 VIAL2 mlHistorical