Nuedexta
These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
c8cce784-8c5f-415b-8068-76e5d481d159
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Otsuka America Pharmaceutical, Inc
DUNS: 008314390
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextromethorphan hydrobromide and quinidine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59148-053
Application NumberNDA021879
Product Classification
M
Marketing Category
C73594
G
Generic Name
dextromethorphan hydrobromide and quinidine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2022
FDA Product Classification
INGREDIENTS (2)
dextromethorphan hydrobromideActive
Quantity: 20 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
QUINIDINE SULFATEActive
Quantity: 10 mg in 1 1
Code: J13S2394HE
Classification: ACTIB