hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-096
Product ID 68382-096_8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040657
Listing Expiration 2026-12-31
Marketing Start 2008-01-03

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382096
Hyphenated Format 68382-096

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 ANDA040657 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05)
  • 100 BLISTER PACK in 1 CARTON (68382-096-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30)
source: ndc

Packages (3)

68382-096-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01) 68382-096-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05) 68382-096-77 100 BLISTER PACK in 1 CARTON (68382-096-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30)

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": "8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21a", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["805a1acd-2e0d-48f1-af6b-0e5d8e06c228"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-096-01)", "package_ndc": "68382-096-01", "marketing_start_date": "20080103"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-096-05)", "package_ndc": "68382-096-05", "marketing_start_date": "20080103"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-096-77)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-096-30)", "package_ndc": "68382-096-77", "marketing_start_date": "20080103"}], "brand_name": "Hydroxychloroquine sulfate", "product_id": "68382-096_8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "68382-096", "generic_name": "Hydroxychloroquine sulfate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA040657", "marketing_category": "ANDA", "marketing_start_date": "20080103", "listing_expiration_date": "20261231"}