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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-335
Application NumberNDA011265
Product Classification
M
Marketing Category
C73605
G
Generic Name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
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