NDC Code(s) : 35356-118-30, 35356-333-30, 35356-339-30, 35356-339-00
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AVINZA morphine sulfate CAPSULE, COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-118(NDC:60793-606)
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
FUMARIC ACID(UNII: 88XHZ13131)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color green (BLUISH-GREEN), blue (BLUISH-GREEN), white Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code AVINZA;60;mg;506
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-118-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021260 10/25/2011
AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-333(NDC:60793-607)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE90 mg
Inactive Ingredients
Ingredient Name Strength
FUMARIC ACID(UNII: 88XHZ13131)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color red, white Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code AVINZA;90;mg;507
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-333-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021260 10/25/2011
AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-339(NDC:60793-608)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C) 		MORPHINE120 mg
Inactive Ingredients
Ingredient Name Strength
FUMARIC ACID(UNII: 88XHZ13131)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color blue, purple (VIOLET), white Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code AVINZA;120;mg;508
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-339-3030 in 1 BOTTLE, GLASS
2NDC:35356-339-00100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021260 10/25/2011

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