DICLOFENAC SODIUM- declofenac sodium tablet, delayed release 
DIRECT RX

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DICLOFENAC SODIUM DR 75mg 20 TABS

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

MEDICATION GUIDE

PACKAGE LABEL- 75 mg container label

DICLOFENAC SODIUM 75mg 20 TABS

DICLOFENAC SODIUM 
declofenac sodium tablet, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-686(NDC:16571-201)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM75 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorbrown (Light Brown) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code P;75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-686-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07786303/22/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-686)

Revised: 4/2016
Document Id: 3104cae3-5e37-6c6e-e054-00144ff88e88
Set id: 3104cae3-5e36-6c6e-e054-00144ff88e88
Version: 1
Effective Time: 20160421
 
DIRECT RX