hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0897
Product ID 71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040657
Listing Expiration 2026-12-31
Marketing Start 2008-01-03

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350897
Hyphenated Format 71335-0897

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 ANDA040657 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (71335-0897-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-0897-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0897-3)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71335-0897-4)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-0897-5)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-0897-6)
  • 10 TABLET, FILM COATED in 1 BOTTLE (71335-0897-7)
  • 14 TABLET, FILM COATED in 1 BOTTLE (71335-0897-8)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71335-0897-9)
source: ndc

Packages (9)

71335-0897-1 100 TABLET, FILM COATED in 1 BOTTLE (71335-0897-1) 71335-0897-2 30 TABLET, FILM COATED in 1 BOTTLE (71335-0897-2) 71335-0897-3 60 TABLET, FILM COATED in 1 BOTTLE (71335-0897-3) 71335-0897-4 180 TABLET, FILM COATED in 1 BOTTLE (71335-0897-4) 71335-0897-5 90 TABLET, FILM COATED in 1 BOTTLE (71335-0897-5) 71335-0897-6 120 TABLET, FILM COATED in 1 BOTTLE (71335-0897-6) 71335-0897-7 10 TABLET, FILM COATED in 1 BOTTLE (71335-0897-7) 71335-0897-8 14 TABLET, FILM COATED in 1 BOTTLE (71335-0897-8) 71335-0897-9 20 TABLET, FILM COATED in 1 BOTTLE (71335-0897-9)

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": "c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["f618a091-ade1-4c39-ab76-f6218b606e05"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71335-0897-1)", "package_ndc": "71335-0897-1", "marketing_start_date": "20200714"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0897-2)", "package_ndc": "71335-0897-2", "marketing_start_date": "20200313"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0897-3)", "package_ndc": "71335-0897-3", "marketing_start_date": "20180706"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71335-0897-4)", "package_ndc": "71335-0897-4", "marketing_start_date": "20180710"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0897-5)", "package_ndc": "71335-0897-5", "marketing_start_date": "20190225"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-0897-6)", "package_ndc": "71335-0897-6", "marketing_start_date": "20240709"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71335-0897-7)", "package_ndc": "71335-0897-7", "marketing_start_date": "20240709"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (71335-0897-8)", "package_ndc": "71335-0897-8", "marketing_start_date": "20240709"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71335-0897-9)", "package_ndc": "71335-0897-9", "marketing_start_date": "20240709"}], "brand_name": "Hydroxychloroquine sulfate", "product_id": "71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "71335-0897", "generic_name": "Hydroxychloroquine sulfate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA040657", "marketing_category": "ANDA", "marketing_start_date": "20080103", "listing_expiration_date": "20261231"}