Contrave
These highlights do not include all the information needed to use CONTRAVE safely and effectively. See full prescribing information for CONTRAVE. CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets Initial U.S. Approval: 2014
Approved
Approval ID
9889a75d-4197-496c-aae1-15c9058c1d1b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
naltrexone hydrochloride and bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-2945
Application NumberNDA200063
Product Classification
M
Marketing Category
C73594
G
Generic Name
naltrexone hydrochloride and bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2019
FDA Product Classification
INGREDIENTS (2)
NALTREXONE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: Z6375YW9SF
Classification: ACTIB
BUPROPION HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB