FDA.reportPublic FDA data

RISPERDAL M-TAB

Product NDC
50458-395
11-digit product format
504580395
Labeler code
50458
Product ID
50458-395_43556c05-69ec-1276-e063-6294a90a968e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA021444
Marketing category
NDA
Marketing start
2003-04-02
Substance
RISPERIDONE
Active strength
.5 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
RISPERDAL M-TAB
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui104781, 104782, 104783, 104784, 199387, 211489, 262222, 312829, 312830, 312831, 312832, 314211, 401953, 401954, 403825, 616698, 616705, 630890, 630974, 806297

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
50458-395-28RISPERDAL M-TAB4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING442
50458-395-28RISPERDAL M-TAB7 in 1 BOXTABLET, ORALLY DISINTEGRATING742
50458-395-30RISPERDAL M-TAB30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING3042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-395-28EA - Each50458-395a45916ef-8b2e-4456-b165-6e6888a250f912012-07-24
50458-395-30EA - Each50458-3959c0b5284-028b-48fe-bcc9-6fd91f7c030e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
risperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
risperidoneACTIVE MOIETYL6UH7ZF8HCRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
Aluminum OxideINACTIVE INGREDIENTLMI26O6933RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
aspartameINACTIVE INGREDIENTZ0H242BBR1RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ERISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
ferric oxide redINACTIVE INGREDIENT1K09F3G675RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
gelatinINACTIVE INGREDIENT2G86QN327LRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
glycineINACTIVE INGREDIENTTE7660XO1CRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
hypromellosesINACTIVE INGREDIENT3NXW29V3WORISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
magnesium stearateINACTIVE INGREDIENT70097M6I30RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
mannitolINACTIVE INGREDIENT3OWL53L36ARISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
peppermint oilINACTIVE INGREDIENTAV092KU4JHRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
propylene glycolINACTIVE INGREDIENT6DC9Q167V3RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
sodium hydroxideINACTIVE INGREDIENT55X04QC32IRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
starch, cornINACTIVE INGREDIENTO8232NY3SJRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
talcINACTIVE INGREDIENT7SEV7J4R1URISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
tartaric acidINACTIVE INGREDIENTW4888I119HRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
waterINACTIVE INGREDIENT059QF0KO0RRISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
xanthan gumINACTIVE INGREDIENTTTV12P4NEERISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-395RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]40Current NDC, Legacy NDC, 3 package rows20250228_7e117c7e-02fc-4343-92a1-230061dfc5e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50458-395-28504580395284 in 1 BLISTER PACKHistorical
50458-395-305045803953030 in 1 BLISTER PACKHistorical