NDC Code(s) : 63629-4667-1, 63629-4667-2, 63629-4667-3
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-4667(NDC:42858-805)
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 SULFATE200 mg
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code ABG;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-4667-1 60 in 1 BOTTLE Type 0: Not a Combination Product07/02/2012
2NDC:63629-4667-2 90 in 1 BOTTLE Type 0: Not a Combination Product07/02/2012
3NDC:63629-4667-3 30 in 1 BOTTLE Type 0: Not a Combination Product07/02/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074769 01/14/2011 06/01/2013

PRINCIPAL DISPLAY PANEL

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