NDC Code(s) : 63629-4695-1
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kadian morphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-4695(NDC:46987-326)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE SULFATE60 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
DIETHYL PHTHALATE(UNII: UF064M00AF)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code Kadian;60;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-4695-160 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020616 04/07/2009

PRINCIPAL DISPLAY PANEL

Label