FDA.reportPublic FDA data

Risperidone M-TAB

Product NDC
50458-601
11-digit product format
504580601
Labeler code
50458
Product ID
50458-601_3e524f1e-7ea8-11e8-83da-f59c9d46d017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Janssen Pharmaceutical, Inc.
Application
NDA021444
Marketing category
NDA
Marketing start
2003-04-02
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-601-28Risperidone M-TAB7 in 1 BOXTABLET, ORALLY DISINTEGRATING733
50458-601-28Risperidone M-TAB4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING433
50458-601-30Risperidone M-TAB30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING3033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-601-28EA - Each50458-601068e83b0-1167-4d1e-9ebe-15cd702cbde712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
risperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
risperidoneACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
Aluminum OxideINACTIVE INGREDIENTLMI26O6933RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
aspartameINACTIVE INGREDIENTZ0H242BBR1RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27ERISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
ferric oxide redINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
gelatinINACTIVE INGREDIENT2G86QN327LRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
glycineINACTIVE INGREDIENTTE7660XO1CRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
magnesium stearateINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
mannitolINACTIVE INGREDIENT3OWL53L36ARISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
peppermint oilINACTIVE INGREDIENTAV092KU4JHRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
propylene glycolINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32IRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
starch, cornINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
talcINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
tartaric acidINACTIVE INGREDIENTW4888I119HRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
waterINACTIVE INGREDIENT059QF0KO0RRISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10
xanthan gumINACTIVE INGREDIENTTTV12P4NEERISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-601RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]32Legacy NDC, 3 package rows20250302_701e1cd8-2868-4d29-85a9-a2212c88165f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403825risperiDONE 0.5 MG Disintegrating Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
312829risperiDONE 0.5 MG Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
401953risperiDONE 1 MG Disintegrating Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
199387risperiDONE 1 MG in 1 mL Oral SolutionPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
312830risperiDONE 1 MG Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
401954risperiDONE 2 MG Disintegrating Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
312831risperiDONE 2 MG Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
616698risperiDONE 3 MG Disintegrating Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
312832risperiDONE 3 MG Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
616705risperiDONE 4 MG Disintegrating Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
314211risperiDONE 4 MG Oral TabletPSN701e1cd8-2868-4d29-85a9-a2212c88165f33
403825risperidone 0.5 MG Disintegrating Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
312829risperidone 0.5 MG Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
401953risperidone 1 MG Disintegrating Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
312830risperidone 1 MG Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
199387risperidone 1 MG/ML Oral SolutionSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
401954risperidone 2 MG Disintegrating Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
312831risperidone 2 MG Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
616698risperidone 3 MG Disintegrating Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
312832risperidone 3 MG Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
616705risperidone 4 MG Disintegrating Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
314211risperidone 4 MG Oral TabletSCD701e1cd8-2868-4d29-85a9-a2212c88165f33
199387risperidone 1 MG per 1 ML Oral SolutionSY701e1cd8-2868-4d29-85a9-a2212c88165f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50458-601-28504580601287 in 1 BOXHistorical
50458-601-305045806013030 in 1 BLISTER PACKHistorical