Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine Phosphate Oral Solution, USP
Approved
Approval ID
83a536d8-385d-46ed-9cd2-47b7efe96ccf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 5
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 Code50383-340
Application NumberANDA040119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2022
FDA Product Classification
INGREDIENTS (11)
CODEINE PHOSPHATEActive
Quantity: 36 mg in 15 mL
Code: GSL05Y1MN6
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETAMINOPHENActive
Quantity: 360 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Acetaminophen and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-338
Application NumberANDA040119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2022
FDA Product Classification
INGREDIENTS (11)
ACETAMINOPHENActive
Quantity: 240 mg in 10 mL
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 24 mg in 10 mL
Code: GSL05Y1MN6
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Acetaminophen and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-339
Application NumberANDA040119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2022
FDA Product Classification
INGREDIENTS (11)
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
ACETAMINOPHENActive
Quantity: 300 mg in 12.5 mL
Code: 362O9ITL9D
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CODEINE PHOSPHATEActive
Quantity: 30 mg in 12.5 mL
Code: GSL05Y1MN6
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Acetaminophen and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-079
Application NumberANDA040119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2022
FDA Product Classification
INGREDIENTS (11)
ACETAMINOPHENActive
Quantity: 120 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CODEINE PHOSPHATEActive
Quantity: 12 mg in 5 mL
Code: GSL05Y1MN6
Classification: ACTIB
Acetaminophen and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-337
Application NumberANDA040119
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2022
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ACETAMINOPHENActive
Quantity: 120 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 12 mg in 5 mL
Code: GSL05Y1MN6
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT