NDC 50090-2868

CONTRAVE

Naltrexone Hydrochloride And Bupropion Hydrochloride

CONTRAVE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Naltrexone Hydrochloride; Bupropion Hydrochloride.

• Product ID: 50090-2868_c5a82f8e-c627-4d42-8046-47c94ed56884
• NDC: 50090-2868
• Product Type: Human Prescription Drug
• Proprietary Name: CONTRAVE
• Generic Name: Naltrexone Hydrochloride And Bupropion Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-10
• Marketing Category: NDA / NDA
• Application Number: NDA200063
• Labeler Name: A-S Medication Solutions
• Substance Name: NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/1; mg/1
• Pharm 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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-2868-0

120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2868-0)

• Marketing Start Date: 2017-02-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-2868-0 [50090286800]

CONTRAVE TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200063
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-15
• Marketing End Date: 2018-09-30

Drug Details

Active Ingredients

Ingredient	Strength
NALTREXONE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: f074eeef-312c-4e7d-869d-79c24e0c514e
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • Z6375YW9SF
  • ZG7E5POY8O
• RxNorm Concept Unique ID - RxCUI:
  • 1551468
  • 1551474

Pharmacological Class

• 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 Crossover Matching brand name "CONTRAVE" or generic name "Naltrexone Hydrochloride And Bupropion Hydrochloride"

NDC	Brand Name	Generic Name
43063-772	Contrave	naltrexone hydrochloride and bupropion hydrochloride
50090-2868	CONTRAVE	naltrexone hydrochloride and bupropion hydrochloride
50090-2945	Contrave	naltrexone hydrochloride and bupropion hydrochloride
51267-890	Contrave	naltrexone hydrochloride and bupropion hydrochloride
64764-890	CONTRAVE	naltrexone hydrochloride and bupropion hydrochloride