NDC 63629-4667-2
API & Excipient Details

Morphine Sulfate marketed by Bryant Ranch Prepack under NDC Code 63629-4667-2

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	200 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-4667-1	60 in 1 BOTTLE Type 0: Not a Combination Product	07/02/2012
2	NDC:63629-4667-2	90 in 1 BOTTLE Type 0: Not a Combination Product	07/02/2012
3	NDC:63629-4667-3	30 in 1 BOTTLE Type 0: Not a Combination Product	07/02/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074769	01/14/2011	06/01/2013

PRINCIPAL DISPLAY PANEL