hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: ipca laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Ipca Laboratories Limited

Identifiers & Regulatory

Product NDC 83980-001
Product ID 83980-001_31f4188d-1c26-4aab-aa12-354329160a39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040766
Listing Expiration 2026-12-31
Marketing Start 2024-06-03

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83980001
Hyphenated Format 83980-001

Supplemental Identifiers

RxCUI
979092
UPC
0383980001015
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 ANDA040766 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (83980-001-10)
  • 10 TABLET, FILM COATED in 1 BOTTLE (83980-001-97)
source: ndc

Packages (4)

83980-001-01 100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01) 83980-001-05 500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05) 83980-001-10 1000 TABLET, FILM COATED in 1 BOTTLE (83980-001-10) 83980-001-97 10 TABLET, FILM COATED in 1 BOTTLE (83980-001-97)

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": "31f4188d-1c26-4aab-aa12-354329160a39", "openfda": {"upc": ["0383980001015"], "unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["9dfa0ff8-e8cf-47f9-847a-b86f23dc39df"], "manufacturer_name": ["Ipca Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01)", "package_ndc": "83980-001-01", "marketing_start_date": "20240603"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05)", "package_ndc": "83980-001-05", "marketing_start_date": "20240603"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (83980-001-10)", "package_ndc": "83980-001-10", "marketing_start_date": "20240603"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (83980-001-97)", "package_ndc": "83980-001-97", "marketing_start_date": "20240603"}], "brand_name": "Hydroxychloroquine Sulfate", "product_id": "83980-001_31f4188d-1c26-4aab-aa12-354329160a39", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "83980-001", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "Ipca Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine Sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA040766", "marketing_category": "ANDA", "marketing_start_date": "20240603", "listing_expiration_date": "20261231"}