hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 400 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-131
Product ID 43598-131_45c22bbf-6332-4f7f-b77e-8ac613435821
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210441
Listing Expiration 2026-12-31
Marketing Start 2022-10-24

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598131
Hyphenated Format 43598-131

Supplemental Identifiers

RxCUI
979092 1119312 2569281 2569283
UPC
0343598132051 0343598133058 0343598133010 0343598721019
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 ANDA210441 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (43598-131-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-131-05)
source: ndc

Packages (2)

43598-131-01 100 TABLET, FILM COATED in 1 BOTTLE (43598-131-01) 43598-131-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-131-05)

Ingredients (1)

hydroxychloroquine sulfate (400 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": "45c22bbf-6332-4f7f-b77e-8ac613435821", "openfda": {"upc": ["0343598132051", "0343598133058", "0343598133010", "0343598721019"], "unii": ["8Q2869CNVH"], "rxcui": ["979092", "1119312", "2569281", "2569283"], "spl_set_id": ["452092b4-7a8f-4d19-8113-f1c2a948d3d8"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (43598-131-01)", "package_ndc": "43598-131-01", "marketing_start_date": "20221024"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-131-05)", "package_ndc": "43598-131-05", "marketing_start_date": "20221024"}], "brand_name": "HYDROXYCHLOROQUINE SULFATE", "product_id": "43598-131_45c22bbf-6332-4f7f-b77e-8ac613435821", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "43598-131", "generic_name": "HYDROXYCHLOROQUINE SULFATE", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYCHLOROQUINE SULFATE", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "400 mg/1"}], "application_number": "ANDA210441", "marketing_category": "ANDA", "marketing_start_date": "20221024", "listing_expiration_date": "20261231"}