hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-506
Product ID 71610-506_2027b984-d53d-41c0-914b-ff66535e0e51
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 71610506
Hyphenated Format 71610-506

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
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-506-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-506-53)
source: ndc

Packages (2)

71610-506-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-506-30) 71610-506-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-506-53)

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": "2027b984-d53d-41c0-914b-ff66535e0e51", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["90111c26-cd12-4a45-a25f-8d83c83c80de"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-506-30)", "package_ndc": "71610-506-30", "marketing_start_date": "20201222"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-506-53)", "package_ndc": "71610-506-53", "marketing_start_date": "20201222"}], "brand_name": "Hydroxychloroquine sulfate", "product_id": "71610-506_2027b984-d53d-41c0-914b-ff66535e0e51", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "71610-506", "generic_name": "Hydroxychloroquine sulfate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}