Dextromethorphan Hydrobromide and Promethazine Hydrochloride
PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP
Approved
Approval ID
ba7ad7f8-3261-4977-a13a-f6e07c510a9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2022
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextromethorphan Hydrobromide and Promethazine Hydrochloride
PRODUCT DETAILS
NDC Product Code17856-0604
Application NumberANDA088864
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 24, 2022
Generic NameDextromethorphan Hydrobromide and Promethazine Hydrochloride
INGREDIENTS (17)
Dextromethorphan HydrobromideActive
Quantity: 15 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Promethazine HydrochlorideActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PINEAPPLEInactive
Code: 2A88ZO081O
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT