Promethazine/Codeine
Promethazine/Codeine
Approved
Approval ID
fd268952-e5c0-75ba-e053-6294a90a7410
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2023
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine/Codeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-486
Application NumberANDA200386
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine/Codeine
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2023
FDA Product Classification
INGREDIENTS (19)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CODEINE PHOSPHATEActive
Quantity: 10 mg in 5 mL
Code: GSL05Y1MN6
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
PEACHInactive
Code: 3OKE88I3QG
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINTInactive
Code: FV98Z8GITP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT