RISPERIDONE (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1MG BOTTLE LABEL

risperiDONE Tablets, USP

1 mg

Rx only

image
(click image for full-size original)
RISPERIDONE risperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-908(NDC:27241-001)
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
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND (CIRCULAR) Size 8mm
Flavor Imprint Code RI3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-908-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-908-60 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201003 03/28/2014
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-908)

Revised: 06/2022 PD-Rx Pharmaceuticals, Inc.

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