NDC Code(s) : 0078-0436-05
Packager : Novartis Pharmaceuticals Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cataflamdiclofenac potassium TABLET, SUGAR COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0436
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC POTASSIUM(UNII: L4D5UA6CB4)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC POTASSIUM50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SUCROSE(UNII: C151H8M554)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BROWN (light brown) Score no score
Shape ROUND (round, biconvex) Size 8 mm
Flavor Imprint Code Cataflam;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0078-0436-05100 in 1 BOTTLE Type 0: Not a Combination Product24/11/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020142 11/24/1993 01/01/2017

PRINCIPAL DISPLAY PANEL

Package Label –   50 mg

Rx Only             NDC 0078-0436-05

CATAFLAM® (diclofenac potassium)

100 Tablets

Dispense in tight container (USP).

PHARMACIST: Dispense with Medication Guide attached or provided separately.

PRINCIPAL DISPLAY PANEL Package Label – 50 mg Rx Only NDC 0078-0436-05 Cataflam® (diclofenac potassium) 100 Tablets