Risperidone

Product NDC
0480-1342
11-digit product format
004801342
Labeler code
0480
Product ID
0480-1342_7cf4d36f-baab-4a9e-8a17-aeb0d6dd7918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
KIT
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA214068
Marketing category
ANDA
Marketing start
2023-12-11
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Risperidone
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui402010, 402011, 402012, 706822

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-1342-08Risperidone1 in 1 CARTONKIT13
0480-9734-01Risperidone2 mL in 1 VIALINJECTION, POWDER, FOR SUSPENSIO2 mL37.5 mg in 2mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-1342RISPERIDONE KIT [TEVA PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20250402_32c0f081-b418-4c1c-b39e-eb5c344043c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
706822risperiDONE 12.5 MG Extended Release InjectionPSN32c0f081-b418-4c1c-b39e-eb5c344043c73
402010risperiDONE 25 MG Extended Release InjectionPSN32c0f081-b418-4c1c-b39e-eb5c344043c73
402011risperiDONE 37.5 MG Extended Release InjectionPSN32c0f081-b418-4c1c-b39e-eb5c344043c73
402012risperiDONE 50 MG Extended Release InjectionPSN32c0f081-b418-4c1c-b39e-eb5c344043c73
706822risperidone 12.5 MG InjectionSCD32c0f081-b418-4c1c-b39e-eb5c344043c73
402010risperidone 25 MG InjectionSCD32c0f081-b418-4c1c-b39e-eb5c344043c73
402011risperidone 37.5 MG InjectionSCD32c0f081-b418-4c1c-b39e-eb5c344043c73
402012risperidone 50 MG InjectionSCD32c0f081-b418-4c1c-b39e-eb5c344043c73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-1342-08004801342081 KIT in 1 CARTON (0480-1342-08) * 2 mL in 1 VIAL (0480-9734-01) * 2 mL in 1 SYRINGE (0480-1200-21) 1 kit2023-12-11NoNoCurrent
0480-9734-01004809734012 mL in 1 VIAL2 mlHistorical