promethazine hydrochloride and codeine phosphate
These highlights do not include all the information needed to use PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HYDROCHLORIDE and CODEINE PHOSPHATE Oral Solution, CV Initial U.S. Approval: 1952
Approved
Approval ID
14f50f2c-ee0e-4345-b6c6-80bd50171772
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2018
Manufacturers
FDA
Nostrum Laboratories, Inc.
DUNS: 791055549
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 Code70408-185
Application NumberANDA090180
Product Classification
M
Marketing Category
C73584
G
Generic Name
promethazine hydrochloride and codeine phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2018
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
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT