MORPHINE SULFATE
These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
Approved
Approval ID
07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2022
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
Products 2
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 Code67877-670
Application NumberANDA212451
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2021
FDA Product Classification
INGREDIENTS (6)
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MORPHINE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-671
Application NumberANDA212451
Product Classification
M
Marketing Category
C73584
G
Generic Name
MORPHINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2021
FDA Product Classification
INGREDIENTS (6)
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT