NDC 43063-772

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 Pd-rx Pharmaceuticals, Inc.. The primary component is Naltrexone Hydrochloride; Bupropion Hydrochloride.

• Product ID: 43063-772_8384b028-7ae8-2a7b-e053-2a91aa0a342c
• NDC: 43063-772
• 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: PD-Rx Pharmaceuticals, 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43063-772-70

70 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-772-70)

• Marketing Start Date: 2017-06-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43063-772-70 [43063077270]

Contrave Extended-Release TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200063
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-16

Drug Details

Active Ingredients

Ingredient	Strength
NALTREXONE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 46778426-be0d-4df5-a8c1-2345d8efd241
• Manufacturer:
  • PD-Rx Pharmaceuticals, 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]

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