Risperidone

Product NDC
62135-604
11-digit product format
621350604
Labeler code
62135
Product ID
62135-604_151f66f3-99b5-6d4d-e063-6394a90a1648
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA077543
Marketing category
ANDA
Marketing start
2011-05-18
Substance
RISPERIDONE
Active strength
3 mg/1
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
RISPERIDONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312828, 312829, 312830, 312831, 312832, 314211

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-604-60Risperidone60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-604-60EA - Each62135-604f10cd263-0961-42cb-8fd2-4045d0ed658612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-604RISPERIDONE TABLET, FILM COATED [CHARTWELL RX, LLC]3Current NDC, 1 package rows20240403_12a479c4-a84a-4308-b89f-be0315826fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN12a479c4-a84a-4308-b89f-be0315826fd53
312829risperiDONE 0.5 MG Oral TabletPSN12a479c4-a84a-4308-b89f-be0315826fd53
312830risperiDONE 1 MG Oral TabletPSN12a479c4-a84a-4308-b89f-be0315826fd53
312831risperiDONE 2 MG Oral TabletPSN12a479c4-a84a-4308-b89f-be0315826fd53
312832risperiDONE 3 MG Oral TabletPSN12a479c4-a84a-4308-b89f-be0315826fd53
314211risperiDONE 4 MG Oral TabletPSN12a479c4-a84a-4308-b89f-be0315826fd53
312828risperidone 0.25 MG Oral TabletSCD12a479c4-a84a-4308-b89f-be0315826fd53
312829risperidone 0.5 MG Oral TabletSCD12a479c4-a84a-4308-b89f-be0315826fd53
312830risperidone 1 MG Oral TabletSCD12a479c4-a84a-4308-b89f-be0315826fd53
312831risperidone 2 MG Oral TabletSCD12a479c4-a84a-4308-b89f-be0315826fd53
312832risperidone 3 MG Oral TabletSCD12a479c4-a84a-4308-b89f-be0315826fd53
314211risperidone 4 MG Oral TabletSCD12a479c4-a84a-4308-b89f-be0315826fd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-604-606213506046060 TABLET, FILM COATED in 1 BOTTLE (62135-604-60) 2023-12-29NoNoCurrent