NDC 50090-2945

Contrave Extended-Release

Naltrexone Hydrochloride And Bupropion Hydrochloride

Contrave Extended-Release is a Oral Tablet, 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: 50090-2945_b09fa8c2-a435-44e0-8104-dd8318a76642
• NDC: 50090-2945
• Product Type: Human Prescription Drug
• Proprietary Name: Contrave Extended-Release
• Generic Name: Naltrexone Hydrochloride And Bupropion Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-22
• 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 50090-2945-0

120 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-2945-0)

• Marketing Start Date: 2017-03-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-2945-0 [50090294500]

Contrave Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200063
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-03-30

Drug Details

Active Ingredients

Ingredient	Strength
NALTREXONE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 9889a75d-4197-496c-aae1-15c9058c1d1b
• 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 Extended-Release" 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