hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler laurus labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-971
Product ID 42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210959
Listing Expiration 2026-12-31
Marketing Start 2023-03-06

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385971
Hyphenated Format 42385-971

Supplemental Identifiers

RxCUI
979092
UPC
0342385971606
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 ANDA210959 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42385-971-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42385-971-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11)
  • 60 TABLET, FILM COATED in 1 BOTTLE (42385-971-60)
source: ndc

Packages (4)

42385-971-01 100 TABLET, FILM COATED in 1 BOTTLE (42385-971-01) 42385-971-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-971-05) 42385-971-11 1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11) 42385-971-60 60 TABLET, FILM COATED in 1 BOTTLE (42385-971-60)

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": "5db4ef8e-532f-4bbe-94ec-489704e93be7", "openfda": {"upc": ["0342385971606"], "unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["04d8fdbf-8829-4469-a341-8af2a2d91ccc"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42385-971-01)", "package_ndc": "42385-971-01", "marketing_start_date": "20230306"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42385-971-05)", "package_ndc": "42385-971-05", "marketing_start_date": "20230306"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11)", "package_ndc": "42385-971-11", "marketing_start_date": "20230306"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (42385-971-60)", "package_ndc": "42385-971-60", "marketing_start_date": "20230306"}], "brand_name": "HYDROXYCHLOROQUINE SULFATE", "product_id": "42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "42385-971", "generic_name": "HYDROXYCHLOROQUINE SULFATE", "labeler_name": "Laurus Labs Limited", "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": "20230306", "listing_expiration_date": "20261231"}