RISPERIDONE

Product NDC
55648-572
11-digit product format
556480572
Labeler code
55648
Product ID
55648-572_aaa62d0c-37d5-40a9-8940-2f2b7397197f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA078871
Marketing category
ANDA
Marketing start
2008-10-09
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
4 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-572-01RISPERIDONE30 in 1 BOTTLETABLET, FILM COATED302
55648-572-02RISPERIDONE500 in 1 BOTTLETABLET, FILM COATED5002
55648-572-03RISPERIDONE100 in 1 CARTONTABLET, FILM COATED1002
55648-572-03RISPERIDONE10 in 1 BLISTER PACKTABLET, FILM COATED102
55648-572-04RISPERIDONE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-572RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 5 package rows20121019_e92a97ef-0fe3-40b1-a938-373293a75255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312829risperiDONE 0.5 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312830risperiDONE 1 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312831risperiDONE 2 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312832risperiDONE 3 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
314211risperiDONE 4 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312828risperidone 0.25 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312829risperidone 0.5 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312830risperidone 1 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312831risperidone 2 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312832risperidone 3 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
314211risperidone 4 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-572-015564805720130 in 1 BOTTLEHistorical
55648-572-0255648057202500 in 1 BOTTLEHistorical
55648-572-0355648057203100 in 1 CARTONHistorical
55648-572-045564805720460 in 1 BOTTLEHistorical