risperidone

Product NDC
55154-0180
11-digit product format
551540180
Labeler code
55154
Product ID
55154-0180_85faf8ed-8e0d-451f-a2cb-06d73032703b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078040
Marketing category
ANDA
Marketing start
2025-05-19
Substance
RISPERIDONE
Active strength
.5 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.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312829, 312830

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
55154-0180-0risperidone10 in 1 BAGTABLET, FILM COATED104
55154-0180-0risperidone1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-0180RISPERIDONE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20250523_3ce21196-4aa0-469b-8f04-6650b2c48cb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312829risperiDONE 0.5 MG Oral TabletPSN3ce21196-4aa0-469b-8f04-6650b2c48cb54
312830risperiDONE 1 MG Oral TabletPSN3ce21196-4aa0-469b-8f04-6650b2c48cb54
312829risperidone 0.5 MG Oral TabletSCD3ce21196-4aa0-469b-8f04-6650b2c48cb54
312830risperidone 1 MG Oral TabletSCD3ce21196-4aa0-469b-8f04-6650b2c48cb54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-0180-05515401800010 BLISTER PACK in 1 BAG (55154-0180-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-05-19NoNoHistorical