Diclofenac Sodium Delayed Release Delayed Release (Page 6 of 6)

Diclofenac Sodium Delayed-Release Tablets, USP 75 mg
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DICLOFENAC SODIUM DELAYED RELEASE DELAYED RELEASE diclofenac sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-128(NDC:61442-103)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 75 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
SHELLAC
POLYETHYLENE GLYCOL 2000
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White) Score no score
Shape ROUND (Round) Size 10mm
Flavor Imprint Code CTI;103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-128-30 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075185 11/13/1998
Labeler — Cambridge Therapeutics Technologies, LLC (080072003)

Revised: 06/2017 Cambridge Therapeutics Technologies, LLC

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