hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1544
Product ID 60219-1544_9ed00eb1-8c8a-4ef0-af47-ab11bc98a9d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210577
Listing Expiration 2026-12-31
Marketing Start 2018-05-17

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602191544
Hyphenated Format 60219-1544

Supplemental Identifiers

RxCUI
979092
UNII
8Q2869CNVH

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 hydroxychloroquine sulfate (source: ndc)
Generic Name hydroxychloroquine sulfate (source: ndc)
Application Number ANDA210577 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (60219-1544-1)
source: ndc

Packages (1)

60219-1544-1 100 TABLET, FILM COATED in 1 BOTTLE (60219-1544-1)

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": "9ed00eb1-8c8a-4ef0-af47-ab11bc98a9d1", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["6a9e2fc8-bedf-46d4-9973-328dbcb18061"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (60219-1544-1)", "package_ndc": "60219-1544-1", "marketing_start_date": "20180517"}], "brand_name": "Hydroxychloroquine Sulfate", "product_id": "60219-1544_9ed00eb1-8c8a-4ef0-af47-ab11bc98a9d1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "60219-1544", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine Sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA210577", "marketing_category": "ANDA", "marketing_start_date": "20180517", "listing_expiration_date": "20261231"}