plaquenil

Generic: hydroxychloroquine sulfate

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

Drug Facts

Product Profile

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

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-473
Product ID 71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA009768
Listing Expiration 2026-12-31
Marketing Start 2013-06-28

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610473
Hyphenated Format 71610-473

Supplemental Identifiers

RxCUI
979092 979094
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 plaquenil (source: ndc)
Generic Name hydroxychloroquine sulfate (source: ndc)
Application Number NDA009768 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 4000 TABLET in 1 BOTTLE (71610-473-04)
  • 30 TABLET in 1 BOTTLE (71610-473-30)
  • 60 TABLET in 1 BOTTLE (71610-473-53)
  • 500 TABLET in 1 BOTTLE (71610-473-74)
  • 180 TABLET in 1 BOTTLE (71610-473-80)
source: ndc

Packages (5)

71610-473-04 4000 TABLET in 1 BOTTLE (71610-473-04) 71610-473-30 30 TABLET in 1 BOTTLE (71610-473-30) 71610-473-53 60 TABLET in 1 BOTTLE (71610-473-53) 71610-473-74 500 TABLET in 1 BOTTLE (71610-473-74) 71610-473-80 180 TABLET in 1 BOTTLE (71610-473-80)

Ingredients (1)

hydroxychloroquine sulfate (200 mg/1)

Linked Drug Pages (1)

Plaquenil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1546d08e-f1f4-7d0b-e063-6294a90a633f", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092", "979094"], "spl_set_id": ["eb26c050-fc41-4183-9f8c-86351335fa64"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "4000 TABLET in 1 BOTTLE (71610-473-04)", "package_ndc": "71610-473-04", "marketing_start_date": "20240403"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-473-30)", "package_ndc": "71610-473-30", "marketing_start_date": "20201014"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-473-53)", "package_ndc": "71610-473-53", "marketing_start_date": "20201014"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71610-473-74)", "package_ndc": "71610-473-74", "marketing_start_date": "20230324"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-473-80)", "package_ndc": "71610-473-80", "marketing_start_date": "20201208"}], "brand_name": "Plaquenil", "product_id": "71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "71610-473", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Plaquenil", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "NDA009768", "marketing_category": "NDA", "marketing_start_date": "20130628", "listing_expiration_date": "20261231"}