Risperidone

Product NDC
17856-0674
11-digit product format
178560674
Labeler code
17856
Product ID
17856-0674_e87a7fd3-cf75-418a-853b-2933354ea3e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091384
Marketing category
ANDA
Marketing start
2018-10-31
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0674-1Risperidone1 mL in 1 SYRINGESOLUTION11
17856-0674-1Risperidone120 in 1 BOX, UNIT-DOSESOLUTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0674RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 2 package rows20181101_7d79e841-6316-450a-a44f-475d157eb1ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199387risperiDONE 1 MG in 1 mL Oral SolutionPSN7d79e841-6316-450a-a44f-475d157eb1ec1
199387risperidone 1 MG/ML Oral SolutionSCD7d79e841-6316-450a-a44f-475d157eb1ec1
199387risperidone 1 MG per 1 ML Oral SolutionSY7d79e841-6316-450a-a44f-475d157eb1ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0674-1178560674011 mL in 1 SYRINGE1 mlHistorical