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 71610-961
Product ID 71610-961_427ac308-f737-d1f0-e063-6294a90ae7a0
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 71610961
Hyphenated Format 71610-961

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 ANDA210577 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-961-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-961-53)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-961-80)
source: ndc

Packages (3)

71610-961-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-961-30) 71610-961-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-961-53) 71610-961-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-961-80)

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": "427ac308-f737-d1f0-e063-6294a90ae7a0", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["427ac2fc-8f7f-9725-e063-6394a90a381b"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-961-30)", "package_ndc": "71610-961-30", "marketing_start_date": "20251031"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-961-53)", "package_ndc": "71610-961-53", "marketing_start_date": "20251031"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-961-80)", "package_ndc": "71610-961-80", "marketing_start_date": "20251031"}], "brand_name": "Hydroxychloroquine Sulfate", "product_id": "71610-961_427ac308-f737-d1f0-e063-6294a90ae7a0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "71610-961", "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": "ANDA210577", "marketing_category": "ANDA", "marketing_start_date": "20180517", "listing_expiration_date": "20261231"}