Pentasa capsule

Ingredients and appearance - Product information

Pentasa capsule- Mesalamine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-561
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Mesalamine ( UNII: 4Q81I59GXC)( Mesalamine - UNII: 4Q81I59GXC ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Castor oil ( UNII: D5340Y2I9G)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)
Talc ( UNII: 7SEV7J4R1U)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Gelatin ( UNII: 2G86QN327L)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color blue Score 1
Shape CAPSULE (CAPSULE) Imprint Code PENTASA;500;mg;S429;500;mg
Size 23 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-561-21 120 in 1 CANISTER 2011/10/04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA020049 USA 2011/10/04

Labeler - REMEDYREPACK INC.( 829572556)