NDC 0430-0783-27
API & Excipient Details

Mesalazine marketed by Allergan, Inc. under NDC Code 0430-0783-27

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MESALAMINE(UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)	MESALAMINE	800 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0430-0783-95	24 in 1 CASE	28/05/2008
1		1 in 1 CARTON
1		12 in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:0430-0783-27	12 in 1 CASE	28/05/2008
2		180 in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:0430-0783-00	273572 in 1 DRUM Type 0: Not a Combination Product	28/05/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021830	05/28/2008	03/31/2019

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL