FDA.reportPublic FDA data

Risperidone

Product NDC
17856-1002
11-digit product format
178561002
Labeler code
17856
Product ID
17856-1002_4e93edd5-0d99-324a-e063-6294a90aeedd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA079059
Marketing category
ANDA
Marketing start
2015-03-13
Substance
RISPERIDONE
Active strength
1 mg/mL
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
RISPERIDONE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui199387

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1002-1Risperidone120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-1002-1Risperidone1 mL in 1 SYRINGESOLUTION14
17856-1002-2Risperidone1 mL in 1 SYRINGESOLUTION14
17856-1002-2Risperidone120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-1002-3Risperidone120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-1002-3Risperidone2 mL in 1 SYRINGESOLUTION24
17856-1002-4Risperidone120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-1002-4Risperidone3 mL in 1 SYRINGESOLUTION34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1002RISPERIDONE SOLUTION [ATLANTIC BIOLOGICALS CORP.]1Current NDC, 8 package rows20240921_dc8c6638-f487-49df-a265-78caa93e43d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199387risperiDONE 1 MG in 1 mL Oral SolutionPSNdc8c6638-f487-49df-a265-78caa93e43d84
199387risperidone 1 MG/ML Oral SolutionSCDdc8c6638-f487-49df-a265-78caa93e43d84
199387risperidone 1 MG per 1 ML Oral SolutionSYdc8c6638-f487-49df-a265-78caa93e43d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1002-117856100201120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-1) / 1 mL in 1 SYRINGE120 syringe2024-09-19NoNoCurrent
17856-1002-217856100202120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-2) / 1 mL in 1 SYRINGE120 syringe2024-09-19NoNoCurrent
17856-1002-317856100203120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-3) / 2 mL in 1 SYRINGE120 syringe2024-09-19NoNoCurrent
17856-1002-417856100204120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1002-4) / 3 mL in 1 SYRINGE120 syringe2026-04-01NoNoCurrent