Diclofenac sodium tablet, delayed release

Ingredients and appearance - Product information

Diclofenac sodium tablet, delayed release- Diclofenac sodium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-761
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diclofenac sodium ( UNII: QTG126297Q)( Diclofenac - UNII: 144O8QL0L1 ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Propylene glycol ( UNII: 6DC9Q167V3)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sodium alginate ( UNII: C269C4G2ZQ)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Stearic acid ( UNII: 4ELV7Z65AP)
Ferrosoferric oxide ( UNII: XM0M87F357)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyvinyl acetate phthalate ( UNII: 58QVG85GW3)
Aluminum hydroxide ( UNII: 5QB0T2IUN0)

Product Characteristics

Color WHITE Size 9 mm
Shape ROUND Score 1
Imprint Code R;551

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA074514 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK( 63187-761), RELABEL( 63187-761)

Package/label display panel