Promethazine VC
PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)
Approved
Approval ID
b00b296d-6c34-48c8-9cfb-71ccc5c9a908
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2011
Manufacturers
FDA
Preferred Pharmaceuticals, Inc
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazinehydrochloride and phenylephrine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-9100
Application NumberANDA040654
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazinehydrochloride and phenylephrine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2011
FDA Product Classification
INGREDIENTS (15)
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: 04JA59TNSJ
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT