ACETAMINOPHEN AND CODEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII
Approved
Approval ID
8171ecb8-fc2e-4980-8d43-2f03cf972ac8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2013
Manufacturers
FDA
Mutual Pharmaceutical Company, Inc.
DUNS: 121735955
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-159
Application NumberANDA089671
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2013
FDA Product Classification
INGREDIENTS (9)
AcetaminophenActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
Codeine PhosphateActive
Quantity: 15 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Povidone K90Inactive
Code: RDH86HJV5Z
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
Acetaminophen and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-160
Application NumberANDA089672
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2013
FDA Product Classification
INGREDIENTS (9)
Codeine PhosphateActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
AcetaminophenActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Povidone K90Inactive
Code: RDH86HJV5Z
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Acetaminophen and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-161
Application NumberANDA089673
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2013
FDA Product Classification
INGREDIENTS (9)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
AcetaminophenActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
Codeine PhosphateActive
Quantity: 60 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Povidone K90Inactive
Code: RDH86HJV5Z
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT