contrave extended-release

Generic: naltrexone hydrochloride and bupropion hydrochloride

Labeler: nalpropion pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name contrave extended-release
Generic Name naltrexone hydrochloride and bupropion hydrochloride
Labeler nalpropion pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 90 mg/1, naltrexone hydrochloride 8 mg/1

Manufacturer
Nalpropion Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 51267-890
Product ID 51267-890_8e7e5582-7a35-4ec7-85e7-b88a98d1bd23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200063
Listing Expiration 2026-12-31
Marketing Start 2014-10-22

Pharmacologic Class

Classes
aminoketone [epc] dopamine uptake inhibitors [moa] increased dopamine activity [pe] increased norepinephrine activity [pe] norepinephrine uptake inhibitors [moa] opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51267890
Hyphenated Format 51267-890

Supplemental Identifiers

RxCUI
1551468 1551474
UPC
0351267890997
UNII
ZG7E5POY8O Z6375YW9SF

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name contrave extended-release (source: ndc)
Generic Name naltrexone hydrochloride and bupropion hydrochloride (source: ndc)
Application Number NDA200063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
  • 8 mg/1
source: ndc
Packaging
  • 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)
source: ndc

Packages (2)

51267-890-07 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07) 51267-890-99 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)

Ingredients (2)

bupropion hydrochloride (90 mg/1) naltrexone hydrochloride (8 mg/1)

Linked Drug Pages (1)

Contrave Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8e7e5582-7a35-4ec7-85e7-b88a98d1bd23", "openfda": {"upc": ["0351267890997"], "unii": ["ZG7E5POY8O", "Z6375YW9SF"], "rxcui": ["1551468", "1551474"], "spl_set_id": ["485ff360-32c8-11df-928b-0002a5d5c51b"], "manufacturer_name": ["Nalpropion Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07)", "package_ndc": "51267-890-07", "marketing_start_date": "20210114"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)", "package_ndc": "51267-890-99", "marketing_start_date": "20141022"}], "brand_name": "Contrave Extended-Release", "product_id": "51267-890_8e7e5582-7a35-4ec7-85e7-b88a98d1bd23", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]", "Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "51267-890", "generic_name": "naltrexone hydrochloride and bupropion hydrochloride", "labeler_name": "Nalpropion Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Contrave", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "90 mg/1"}, {"name": "NALTREXONE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "NDA200063", "marketing_category": "NDA", "marketing_start_date": "20141022", "listing_expiration_date": "20261231"}