NDC 64764-890

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 Takeda Pharmaceuticals America, Inc.. The primary component is Naltrexone Hydrochloride; Bupropion Hydrochloride.

• Product ID: 64764-890_ed2da3a6-0614-4bea-8e82-962cbaae6428
• NDC: 64764-890
• 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: Takeda Pharmaceuticals America, Inc.
• 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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 64764-890-00

70 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64764-890-00)

• Marketing Start Date: 2014-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64764-890-99 [64764089099]

CONTRAVE TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200063
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-10
• Marketing End Date: 2019-08-15

NDC 64764-890-00 [64764089000]

CONTRAVE TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200063
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-09-10
• Marketing End Date: 2019-08-15

Drug Details

Active Ingredients

Ingredient	Strength
NALTREXONE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: ed2da3a6-0614-4bea-8e82-962cbaae6428
• Manufacturer:
  • Takeda Pharmaceuticals America, Inc.
• 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]

Medicade Reported Pricing

64764089099 CONTRAVE ER 8-90 MG TABLET

Pricing Unit: EA | Drug Type:

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