Diclofenac Sodium Delayed Release (Page 6 of 6)

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Diclofenac Sod 50mg
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DICLOFENAC SODIUM DELAYED RELEASE
diclofenac sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-059(NDC:0591-0338)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diclofenac Sodium (Diclofenac) Diclofenac Sodium 50 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
TITANIUM DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code WPI;338
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-059-30 30 TABLET, DELAYED RELEASE (WAFER) in 1 BOTTLE None
2 NDC:42254-059-60 60 TABLET, DELAYED RELEASE (WAFER) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075185 04/10/2012
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 01/2012 Rebel Distributors Corp

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