NDC Code(s) : 0430-0783-95, 0430-0783-27, 0430-0783-00
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ASACOL HDmesalamine TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0783
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE(UNII: 4Q81I59GXC)
(MESALAMINE - UNII:4Q81I59GXC) 		MESALAMINE800 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color BROWN (red-brown) Score no score
Shape CAPSULE (capsule-shaped) Size 19 mm
Flavor Imprint Code WC;800
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0430-0783-9524 in 1 CASE 28/05/2008
11 in 1 CARTON
112 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0430-0783-2712 in 1 CASE 28/05/2008
2180 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:0430-0783-00273572 in 1 DRUM Type 0: Not a Combination Product28/05/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021830 05/28/2008 03/31/2019

PRINCIPAL DISPLAY PANEL

NDC 0430-0783-27
Asacol® HD (mesa lamine) delayed-release tablets
800 mg per tablet
Not Bioequivalent to Asacol
180 Tablets
Rx Only asacolHD.com

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0430-0783-27 Asacol® HD (mesalamine) delayed-release tablets 800 mg per tablet Not Bioequivalent to Asacol 180 Tablets Rx Only asacolHD.com

PRINCIPAL DISPLAY PANEL

Asacol 800mg Prnt WC Tabs 300kg WE US

BULK PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Asacol 800mg Prnt WC Tabs 300kg WE US