PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Oral Solution, USP)
Approved
Approval ID
73c76b87-8d98-4d78-ab00-549f3bc3c324
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2023
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
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
NDC Product Code64679-608
Application NumberANDA087953
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 22, 2023
Generic Namepromethazine hydrochloride
INGREDIENTS (16)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
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 RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT