Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine with Dextromethorphan Cough Syrup (Promethazine Hydrochloride 6.25 mg/5 mL & Dextromethorphan Hydrobromide 15 mg/5 mL) Rx only
Approved
Approval ID
16261e9d-2507-4291-99b2-e0b5bf7cf8c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 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 and dextromethorphan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-604
Application NumberANDA088864
Product Classification
M
Marketing Category
C73584
G
Generic Name
promethazine hydrochloride and dextromethorphan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 20, 2023
FDA Product Classification
INGREDIENTS (16)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
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
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 15 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB