naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-242
Product ID 62135-242_1adc57cf-70f9-75b9-e063-6294a90a0de0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207905
Listing Expiration 2026-12-31
Marketing Start 2017-07-21

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135242
Hyphenated Format 62135-242

Supplemental Identifiers

RxCUI
1483744
UPC
0362135242909 0362135242602 0362135242305
UNII
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 naltrexone hydrochloride (source: ndc)
Generic Name naltrexone hydrochloride (source: ndc)
Application Number ANDA207905 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (62135-242-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (62135-242-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90)
source: ndc

Packages (3)

62135-242-30 30 TABLET, FILM COATED in 1 BOTTLE (62135-242-30) 62135-242-60 60 TABLET, FILM COATED in 1 BOTTLE (62135-242-60) 62135-242-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90)

Ingredients (1)

naltrexone hydrochloride (50 mg/1)

Linked Drug Pages (1)

Naltrexone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1adc57cf-70f9-75b9-e063-6294a90a0de0", "openfda": {"upc": ["0362135242909", "0362135242602", "0362135242305"], "unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["adb7c4dc-221a-4d91-9687-0d78913a92ad"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62135-242-30)", "package_ndc": "62135-242-30", "marketing_start_date": "20220105"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (62135-242-60)", "package_ndc": "62135-242-60", "marketing_start_date": "20240611"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90)", "package_ndc": "62135-242-90", "marketing_start_date": "20220105"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "62135-242_1adc57cf-70f9-75b9-e063-6294a90a0de0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "62135-242", "generic_name": "Naltrexone Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naltrexone Hydrochloride", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA207905", "marketing_category": "ANDA", "marketing_start_date": "20170721", "listing_expiration_date": "20261231"}