naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-326
Product ID 47335-326_b0c2b60a-dc96-483b-933e-2fed58b64372
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090356
Listing Expiration 2026-12-31
Marketing Start 2012-02-29

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335326
Hyphenated Format 47335-326

Supplemental Identifiers

RxCUI
1483744
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 ANDA090356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-326-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88)
source: ndc

Packages (4)

47335-326-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08) 47335-326-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18) 47335-326-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-326-83) 47335-326-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88)

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": "b0c2b60a-dc96-483b-933e-2fed58b64372", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["0f30f885-d0cd-4fa6-a8e0-142f08a56792"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)", "package_ndc": "47335-326-08", "marketing_start_date": "20120229"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18)", "package_ndc": "47335-326-18", "marketing_start_date": "20120229"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-326-83)", "package_ndc": "47335-326-83", "marketing_start_date": "20120229"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88)", "package_ndc": "47335-326-88", "marketing_start_date": "20120229"}], "brand_name": "NALTREXONE HYDROCHLORIDE", "product_id": "47335-326_b0c2b60a-dc96-483b-933e-2fed58b64372", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "47335-326", "generic_name": "NALTREXONE HYDROCHLORIDE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALTREXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA090356", "marketing_category": "ANDA", "marketing_start_date": "20120229", "listing_expiration_date": "20261231"}