plaquenil

Generic: hydroxychloroquine sulfate

Labeler: advanz pharma (us) corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name plaquenil
Generic Name hydroxychloroquine sulfate
Labeler advanz pharma (us) corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Advanz Pharma (US) Corp.

Identifiers & Regulatory

Product NDC 59212-562
Product ID 59212-562_87a25f49-2516-4dcc-a305-650393c756b3
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 59212562
Hyphenated Format 59212-562

Supplemental Identifiers

RxCUI
979092 979094
UPC
0359212562104
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 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
  • 100 TABLET in 1 BOTTLE (59212-562-10)
  • 100 TABLET in 1 BOTTLE (59212-562-11)
  • 60 TABLET in 1 BOTTLE (59212-562-60)
source: ndc

Packages (3)

59212-562-10 100 TABLET in 1 BOTTLE (59212-562-10) 59212-562-11 100 TABLET in 1 BOTTLE (59212-562-11) 59212-562-60 60 TABLET in 1 BOTTLE (59212-562-60)

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": "87a25f49-2516-4dcc-a305-650393c756b3", "openfda": {"upc": ["0359212562104"], "unii": ["8Q2869CNVH"], "rxcui": ["979092", "979094"], "spl_set_id": ["34496b43-05a2-45fb-a769-52b12e099341"], "manufacturer_name": ["Advanz Pharma (US) Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59212-562-10)", "package_ndc": "59212-562-10", "marketing_start_date": "20130628"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (59212-562-11)", "package_ndc": "59212-562-11", "marketing_start_date": "20200810"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (59212-562-60)", "package_ndc": "59212-562-60", "marketing_start_date": "20190105"}], "brand_name": "Plaquenil", "product_id": "59212-562_87a25f49-2516-4dcc-a305-650393c756b3", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "59212-562", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "Advanz Pharma (US) Corp.", "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"}