MORPHINE SULFATE
MORPHINE SULFATE ER - C-II 15 mg TABLETS
Approved
Approval ID
225ffea2-7f0e-4340-b39f-4fcad0f545de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
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 Code16590-966
Application NumberANDA074862
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2012
FDA Product Classification
INGREDIENTS (11)
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT