hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxychloroquine sulfate 200 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-412
Product ID 50268-412_47e560c6-bd1f-1264-e063-6394a90a0048
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210441
Listing Expiration 2027-12-31
Marketing Start 2020-05-15

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268412
Hyphenated Format 50268-412

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 ANDA210441 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-412-11)
source: ndc

Packages (1)

50268-412-15 50 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-412-11)

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": "47e560c6-bd1f-1264-e063-6394a90a0048", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["a5b3455a-e842-7d4b-e053-2995a90adee3"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-412-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-412-11)", "package_ndc": "50268-412-15", "marketing_start_date": "20200515"}], "brand_name": "HYDROXYCHLOROQUINE SULFATE", "product_id": "50268-412_47e560c6-bd1f-1264-e063-6394a90a0048", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "50268-412", "generic_name": "HYDROXYCHLOROQUINE SULFATE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYCHLOROQUINE SULFATE", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA210441", "marketing_category": "ANDA", "marketing_start_date": "20200515", "listing_expiration_date": "20271231"}