AVINZA
AVINZA C II(morphine sulfate extended-release capsules)30 mg, 45 mg, 60 mg, 75 mg, 90 mg, 120 mg R Only
Approved
Approval ID
59007321-a6e4-4c98-858e-e824921f6a35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-593
Application NumberNDA021260
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2011
FDA Product Classification
INGREDIENTS (8)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
MORPHINE SULFATEActive
Quantity: 60 mg in 1 1
Code: X3P646A2J0
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-594
Application NumberNDA021260
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2011
FDA Product Classification
INGREDIENTS (8)
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIM
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-597
Application NumberNDA021260
Product Classification
M
Marketing Category
C73594
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2011
FDA Product Classification
INGREDIENTS (8)
MORPHINE SULFATEActive
Quantity: 90 mg in 1 1
Code: X3P646A2J0
Classification: ACTIM
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT