Promethazine Hydrochloride
PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)
Approved
Approval ID
0e8199de-86cb-4450-a118-96927c9d59bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1867
Application NumberANDA087953
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2012
FDA Product Classification
INGREDIENTS (16)
Promethazine HydrochlorideActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT