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Product NDC
50090-2868
11-digit product format
500902868
Labeler code
50090
Product ID
50090-2868_c5a82f8e-c627-4d42-8046-47c94ed56884
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride and bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record