Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine Phosphate Oral Solution USP CV
Approved
Approval ID
95a5d638-3072-4c37-a4cd-f8550328e2c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
Genus Lifesciences Inc.
DUNS: 113290444
Products 1
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 Code64950-374
Application NumberANDA087508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2023
FDA Product Classification
INGREDIENTS (10)
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
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT