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

NDC 65841-641-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 1 mg

Rx only

30 tablets

NDC 65841-642-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 2 mg

Rx only

30 tablets

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