Risperidone

RISPERIDONE- risperidone tablet, orally disintegrating
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-640-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 0.5 mg

Rx only

30 tablets

Risperidone Orally Disintegrating Tablets
(click image for full-size original)

NDC 65841-641-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 1 mg

Rx only

30 tablets

Risperidone Orally Disintegrating Tablets
(click image for full-size original)

NDC 65841-642-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 2 mg

Rx only

30 tablets

Risperidone Orally Disintegrating Tablets
(click image for full-size original)
RISPERIDONE
risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-640
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE (15 MPA.S AT 5%)
MANNITOL
PEPPERMINT
SODIUM LAURYL SULFATE
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-640-06 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078516 06/29/2010
RISPERIDONE
risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-641
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 1 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE (15 MPA.S AT 5%)
MANNITOL
PEPPERMINT
SODIUM LAURYL SULFATE
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-641-06 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078516 06/29/2010
RISPERIDONE
risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-642
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 2 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CALCIUM STEARATE
CROSPOVIDONE (15 MPA.S AT 5%)
MANNITOL
PEPPERMINT
SODIUM LAURYL SULFATE
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-642-06 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078516 06/29/2010
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-640), ANALYSIS (65841-641), ANALYSIS (65841-642), MANUFACTURE (65841-640), MANUFACTURE (65841-641), MANUFACTURE (65841-642)

Revised: 09/2020 Cadila Healthcare Limited

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