MORPHINE SULFATE
MORPHINE SULFATE
Approved
Approval ID
14da9360-2be2-4897-896a-f9739c1b0441
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2015
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code61919-966
Application NumberANDA074862
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2015
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT