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Product NDC

64764-890

11-digit product format

647640890

Labeler code

64764

Product ID

64764-890_ed2da3a6-0614-4bea-8e82-962cbaae6428

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

naltrexone hydrochloride and bupropion hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Takeda Pharmaceuticals America, Inc.

Application

NDA200063

Marketing category

NDA

Marketing start

2014-09-10

Marketing end

0000-00-00

Substance

NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE

Active strength

8 mg/1; mg/1

Pharmacologic classes

Opioid Antagonist [EPC],Opioid Antagonists [MoA],Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record