hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-761
Product ID 57664-761_cb7adb60-886b-4415-9b04-b6d37712bbe0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201691
Listing Expiration 2026-12-31
Marketing Start 2018-06-18

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664761
Hyphenated Format 57664-761

Supplemental Identifiers

RxCUI
979092
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 hydroxychloroquine sulfate (source: ndc)
Generic Name hydroxychloroquine sulfate (source: ndc)
Application Number ANDA201691 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (57664-761-13)
  • 100 TABLET in 1 BOTTLE (57664-761-88)
source: ndc

Packages (2)

57664-761-13 500 TABLET in 1 BOTTLE (57664-761-13) 57664-761-88 100 TABLET in 1 BOTTLE (57664-761-88)

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": "cb7adb60-886b-4415-9b04-b6d37712bbe0", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["6e72fe06-7995-3fd7-e053-2a91aa0a54db"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (57664-761-13)", "package_ndc": "57664-761-13", "marketing_start_date": "20180618"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (57664-761-88)", "package_ndc": "57664-761-88", "marketing_start_date": "20180618"}], "brand_name": "Hydroxychloroquine sulfate", "product_id": "57664-761_cb7adb60-886b-4415-9b04-b6d37712bbe0", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "57664-761", "generic_name": "Hydroxychloroquine sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA201691", "marketing_category": "ANDA", "marketing_start_date": "20180618", "listing_expiration_date": "20261231"}