risperdal m-tab

Generic: risperidone

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperdal m-tab
Generic Name risperidone
Labeler janssen pharmaceuticals, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-325
Product ID 50458-325_43556c05-69ec-1276-e063-6294a90a968e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021444
Listing Expiration 2026-12-31
Marketing Start 2003-04-02

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458325
Hyphenated Format 50458-325

Supplemental Identifiers

RxCUI
104781 104782 104783 104784 199387 211489 262222 312829 312830 312831 312832 314211 401953 401954 403825 616698 616705 630890 630974 806297 806298 806299
UNII
L6UH7ZF8HC
NUI
N0000175430

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name risperdal m-tab (source: ndc)
Generic Name risperidone (source: ndc)
Application Number NDA021444 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied RISPERDAL ® (risperidone) Tablets RISPERDAL ® (risperidone) Tablets are imprinted " JANSSEN " on one side and either "Ris 0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. 0.5 mg red-brown, capsule-shaped tablets: bottles of 60 NDC 50458-302-06, bottles of 500 NDC 50458-302-50, and hospital unit dose blister packs of 100 NDC 50458-302-01. 1 mg white, capsule-shaped tablets: bottles of 60 NDC 50458-300-06, bottles of 500 NDC 50458-300-50, and hospital unit dose blister packs of 100 NDC 50458-300-01. 2 mg orange, capsule-shaped tablets: bottles of 60 NDC 50458-320-06, bottles of 500 NDC 50458-320-50, and hospital unit dose blister packs of 100 NDC 50458-320-01. 3 mg yellow, capsule-shaped tablets: bottles of 60 NDC 50458-330-06, bottles of 500 NDC 50458-330-50, and hospital unit dose blister packs of 100 NDC 50458-330-01. 4 mg green, capsule-shaped tablets: bottles of 60 NDC 50458-350-06 and hospital unit dose blister packs of 100 NDC 50458-350-01. RISPERDAL ® (risperidone) Oral Solution RISPERDAL ® (risperidone) 1 mg/mL Oral Solution (NDC 50458-305-03) is supplied in 30 mL bottles with a calibrated (in milliliters) oral dosing syringe. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL. RISPERDAL ® M-TAB ® (risperidone) Orally Disintegrating Tablets RISPERDAL ® M-TAB ® (risperidone) Orally Disintegrating Tablets are etched on one side with "R0.5", "R1", "R2", "R3", or "R4" according to their respective strengths. RISPERDAL M-TAB Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are packaged in blister packs of 4 (2 × 2) tablets. Orally Disintegrating Tablets 3 mg and 4 mg are packaged in a child-resistant pouch containing a blister with 1 tablet. 0.5 mg light coral, round, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-395-28, and long-term care blister packaging of 30 tablets NDC 50458-395-30. 1 mg light coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-315-28, and long-term care blister packaging of 30 tablets NDC 50458-315-30. 2 mg coral, square, biconvex tablets: 7 blister packages (4 tablets each) per box, NDC 50458-325-28. 3 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-335-28. 4 mg coral, round, biconvex tablets: 28 blisters per box, NDC 50458-355-28. 16.2 Storage and Handling RISPERDAL Tablets should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). Keep out of reach of children.
  • PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label NDC 50458-302-06 RISPERDAL ® (risperiDONE) TABLETS 0.5 mg Each tablet contains: Risperidone 0.5 mg Keep out of reach of children. Rx only 60 Tablets PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL - 1 mg Bottle Label NDC 50458-300-06 RISPERDAL ® (risperiDONE) TABLETS 1 mg Each tablet contains: Risperidone 1 mg Keep out of reach of children. Rx only 60 Tablets PRINCIPAL DISPLAY PANEL - 1 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL - 2 mg Bottle Label NDC 50458-320-06 RISPERDAL ® (risperiDONE) TABLETS 2 mg Each tablet contains: Risperidone 2 mg Keep out of reach of children. Rx only 60 Tablets PRINCIPAL DISPLAY PANEL - 2 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL - 3 mg Bottle Label 60 TABLETS NDC 50458-330-06 RISPERDAL ® (risperiDONE) TABLETS 3 mg Each tablet contains: Risperidone 3 mg Keep out of reach of children. Rx only 60 Tablets PRINCIPAL DISPLAY PANEL - 3 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL - 4 mg Bottle Label 60 TABLETS NDC 50458-350-06 RISPERDAL ® (risperiDONE) TABLETS 4 mg Each tablet contains: Risperidone 4 mg Keep out of reach of children. Rx only 60 Tablets PRINCIPAL DISPLAY PANEL - 4 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Carton NDC 50458-395-28 28 TABLETS Risperdal ® M-TAB ® risperiDONE Orally Disintegrating Tablets 0.5 mg Rx Only Each tablet contains: 0.5 mg risperidone Blister pack 7 cards of 4 tablets janssen PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Carton
  • PRINCIPAL DISPLAY PANEL - 1 mg Tablet Carton NDC 50458-315-28 28 TABLETS Risperdal ® M-TAB ® risperiDONE Orally Disintegrating Tablets 1 mg Rx Only Each tablet contains: 1 mg risperidone Blister pack 7 cards of 4 tablets janssen PRINCIPAL DISPLAY PANEL - 1 mg Tablet Carton
  • PRINCIPAL DISPLAY PANEL - 2 mg Tablet Carton NDC 50458-325-28 28 TABLETS Risperdal ® M-TAB ® risperiDONE Orally Disintegrating Tablets 2 mg Rx Only Each tablet contains: 2 mg risperidone Blister pack 7 cards of 4 tablets janssen PRINCIPAL DISPLAY PANEL - 2 mg Tablet Carton
  • PRINCIPAL DISPLAY PANEL - 3 mg Tablet Carton NDC 50458-335-28 Risperdal ® M-TAB ® risperiDONE Orally Disintegrating Tablets Phenylketonurics: Contains 0.63 mg phenylalanine (a component of aspartame) per 3 mg tablet Each tablet contains: 3 mg risperidone Rx only Dosage: For information or use, see accompanying full Prescribing Information. Product of Ireland Manufactured by: Janssen Ortho, LLC Gurabo, PR 00778 Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 janssen PRINCIPAL DISPLAY PANEL - 3 mg Tablet Carton
  • PRINCIPAL DISPLAY PANEL - 4 mg Tablet Carton NDC 50458-355-28 Risperdal ® M-TAB ® risperiDONE Orally Disintegrating Tablets Phenylketonurics: Contains 0.84 mg phenylalanine (a component of aspartame) per 4 mg tablet Each tablet contains: 4 mg risperidone Rx only Dosage: For information or use, see accompanying full Prescribing Information. Product of Ireland Manufactured by: Janssen Ortho, LLC Gurabo, PR 00778 Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 janssen PRINCIPAL DISPLAY PANEL - 4 mg Tablet Carton
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton NDC 50458-305-03 RISPERDAL ® (risperiDONE) ORAL SOLUTION 1 mg/mL Each 1 mL contains 1 mg of risperidone in an aqueous solution. Rx only 30 mL Johnson&Johnson Risperdal OS 1mg
source: label

Packages (0)

No package records.

Ingredients (1)

risperidone (2 mg/1)

Linked Drug Pages (1)

RISPERDAL, RISPERDAL M-TAB ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
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