NDC Code 35356-339-30 - Morphine Sulfate

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

AVINZA morphine sulfate CAPSULE, COATED, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	60 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35356-118-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021260	10/25/2011

AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE	90 mg

Ingredient Name	Strength
Inactive Ingredients
FUMARIC ACID(UNII: 88XHZ13131)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35356-333-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021260	10/25/2011

AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE	120 mg

Ingredient Name	Strength
Inactive Ingredients
FUMARIC ACID(UNII: 88XHZ13131)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021260	10/25/2011

NDC 35356-339-30
API & Excipient Details