hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-643
Product ID 76420-643_091085d0-27cf-a5cc-e063-6294a90a78ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210959
Listing Expiration 2026-12-31
Marketing Start 2019-09-05

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420643
Hyphenated Format 76420-643

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 ANDA210959 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-643-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-643-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-643-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-643-90)
source: ndc

Packages (4)

76420-643-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-643-01) 76420-643-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-643-30) 76420-643-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-643-60) 76420-643-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-643-90)

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": "091085d0-27cf-a5cc-e063-6294a90a78ce", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["09109827-3053-adc8-e063-6294a90a27a6"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-643-01)", "package_ndc": "76420-643-01", "marketing_start_date": "20231031"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-643-30)", "package_ndc": "76420-643-30", "marketing_start_date": "20231031"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-643-60)", "package_ndc": "76420-643-60", "marketing_start_date": "20231031"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-643-90)", "package_ndc": "76420-643-90", "marketing_start_date": "20231031"}], "brand_name": "Hydroxychloroquine Sulfate", "product_id": "76420-643_091085d0-27cf-a5cc-e063-6294a90a78ce", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "76420-643", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine Sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA210959", "marketing_category": "ANDA", "marketing_start_date": "20190905", "listing_expiration_date": "20261231"}