Promethazine Hydrochloride and Codeine Phosphate
These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CVInitial U.S. Approval: 1952
Approved
Approval ID
9aca56ec-28f8-4679-9f90-ec3e82deb9ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
QUAGEN PHARMACEUTICALS LLC
DUNS: 073645339
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine Hydrochloride and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70752-139
Application NumberANDA214238
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (16)
CODEINE PHOSPHATEActive
Quantity: 10 mg in 5 mL
Code: GSL05Y1MN6
Classification: ACTIB
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT