hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1523
Product ID 67046-1523_2eeafa6f-9d36-b46d-e063-6394a90ade46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040766
Listing Expiration 2026-12-31
Marketing Start 2025-02-24

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461523
Hyphenated Format 67046-1523

Supplemental Identifiers

RxCUI
979092
UNII
8Q2869CNVH

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 hydroxychloroquine sulfate (source: ndc)
Generic Name hydroxychloroquine sulfate (source: ndc)
Application Number ANDA040766 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1523-3)
source: ndc

Packages (1)

67046-1523-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1523-3)

Ingredients (1)

hydroxychloroquine sulfate (200 mg/1)

Linked Drug Pages (1)

Hydroxychloroquine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2eeafa6f-9d36-b46d-e063-6394a90ade46", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["2eeaf562-95f9-bcef-e063-6394a90a1c19"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1523-3)", "package_ndc": "67046-1523-3", "marketing_start_date": "20250224"}], "brand_name": "Hydroxychloroquine Sulfate", "product_id": "67046-1523_2eeafa6f-9d36-b46d-e063-6394a90ade46", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "67046-1523", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine Sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA040766", "marketing_category": "ANDA", "marketing_start_date": "20250224", "listing_expiration_date": "20261231"}