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FDA Approval

Acetaminophen and Codeine Phosphate

CompanyAkorn (DUNS: 117696873)

Effective Date

November 15, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Codeine(36 mg in 15 mL)

Acetaminophen(360 mg in 15 mL)

Registrants (1)

Akorn Operating Company LLC

DUNS Number

117693100

Manufacturing Establishments (1)

Labeler

Akorn

Registrant

Akorn Operating Company LLC

DUNS Number

117696873

Products (5)

Acetaminophen and Codeine Phosphate

NDC Product Code

50383-340

Application Number

ANDA040119

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2022

Ingredients

Code: GSL05Y1MN6Class: ACTIBQuantity: 36 mg in 15 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

CHERRYInactive

Code: BUC5I9595WClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 360 mg in 15 mL

SUCROSEInactive

Code: C151H8M554Class: IACT

Acetaminophen and Codeine Phosphate

NDC Product Code

50383-338

Application Number

ANDA040119

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2022

Ingredients

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 240 mg in 10 mL

Code: GSL05Y1MN6Class: ACTIBQuantity: 24 mg in 10 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

CHERRYInactive

Code: BUC5I9595WClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Acetaminophen and Codeine Phosphate

NDC Product Code

50383-339

Application Number

ANDA040119

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2022

Ingredients

CHERRYInactive

Code: BUC5I9595WClass: IACT

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 12.5 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: GSL05Y1MN6Class: ACTIBQuantity: 30 mg in 12.5 mL

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

Acetaminophen and Codeine Phosphate

NDC Product Code

50383-079

Application Number

ANDA040119

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2022

Ingredients

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 120 mg in 5 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

CHERRYInactive

Code: BUC5I9595WClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: GSL05Y1MN6Class: ACTIBQuantity: 12 mg in 5 mL

Acetaminophen and Codeine Phosphate

NDC Product Code

50383-337

Application Number

ANDA040119

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2022

Ingredients

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 120 mg in 5 mL

Code: GSL05Y1MN6Class: ACTIBQuantity: 12 mg in 5 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

CHERRYInactive

Code: BUC5I9595WClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

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