Risperidone

Product NDC
42291-913
11-digit product format
422910913
Labeler code
42291
Product ID
42291-913_f1eb12af-083e-13a0-e053-2a95a90a8e12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA078071
Marketing category
ANDA
Marketing start
2021-09-10
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
4 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
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
42291-913-50Risperidone500 in 1 BOTTLETABLET5004
42291-913-60Risperidone60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-913RISPERIDONE TABLET [AVKARE]3Legacy NDC, 1 package rows20230111_cc97c0d4-4690-62be-e053-2a95a90a3a0c.zip
42291-913RISPERIDONE TABLET [AVKARE]2Legacy NDC, 1 package rows20230111_cba7628c-30b2-5d26-e053-2a95a90a3e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312829risperiDONE 0.5 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312830risperiDONE 1 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312831risperiDONE 2 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312832risperiDONE 3 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
314211risperiDONE 4 MG Oral TabletPSNcba7628c-30b2-5d26-e053-2a95a90a3e574
312828risperidone 0.25 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312829risperidone 0.5 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312830risperidone 1 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312831risperidone 2 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312832risperidone 3 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
314211risperidone 4 MG Oral TabletSCDcba7628c-30b2-5d26-e053-2a95a90a3e574
312828risperiDONE 0.25 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312829risperiDONE 0.5 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312830risperiDONE 1 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312831risperiDONE 2 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312832risperiDONE 3 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
314211risperiDONE 4 MG Oral TabletPSNcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312828risperidone 0.25 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312829risperidone 0.5 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312830risperidone 1 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312831risperidone 2 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
312832risperidone 3 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3
314211risperidone 4 MG Oral TabletSCDcc97c0d4-4690-62be-e053-2a95a90a3a0c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-913-5042291091350500 TABLET in 1 BOTTLE (42291-913-50) 500 tablet2021-09-100000-00-00NoNoCurrent
42291-913-604229109136060 TABLET in 1 BOTTLE (42291-913-60) 60 tablet2021-09-220000-00-00NoNoCurrent