RISPERIDONE

Product NDC
62135-929
11-digit product format
621350929
Labeler code
62135
Product ID
62135-929_070bbc43-2f78-c14c-e063-6294a90a61f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA202386
Marketing category
ANDA
Marketing start
2015-01-12
Substance
RISPERIDONE
Active strength
1 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RISPERIDONE
Listing expiration
2026-12-31

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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-929-43RISPERIDONE30 mL in 1 BOTTLESOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-929-43ML - Milliliter62135-9296c2facbf-bde4-4192-8f8d-8f85287d94a012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-929RISPERIDONE SOLUTION [CHARTWELL RX, LLC]2Current NDC, Legacy NDC, 1 package rows20231007_66390528-7517-452a-ae76-4338ec7db3ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199387risperiDONE 1 MG in 1 mL Oral SolutionPSN66390528-7517-452a-ae76-4338ec7db3ae2
199387risperidone 1 MG/ML Oral SolutionSCD66390528-7517-452a-ae76-4338ec7db3ae2
199387risperidone 1 MG per 1 ML Oral SolutionSY66390528-7517-452a-ae76-4338ec7db3ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-929-436213509294330 mL in 1 BOTTLE (62135-929-43) 30 ml2022-07-280000-00-00NoNoCurrent