Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Rx Only
Approved
Approval ID
702eb7c0-db4c-4729-b69e-99f64c63c7bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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
NDC Product Code76420-335
Application NumberNDA011265
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic NamePromethazine Hydrochloride and Dextromethorphan Hydrobromide
INGREDIENTS (16)
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 15 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LEVOMENTHOLInactive
Code: BZ1R15MTK7
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT