hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7046
Product ID 0904-7046_a0a69116-862a-4dfa-820f-33e95343edfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210441
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047046
Hyphenated Format 0904-7046

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 CARTON (0904-7046-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-7046-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0904-7046-06 50 BLISTER PACK in 1 CARTON (0904-7046-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-7046-61 100 BLISTER PACK in 1 CARTON (0904-7046-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "a0a69116-862a-4dfa-820f-33e95343edfe", "openfda": {"unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["ebe00e35-ed3d-40f4-9a93-a37b0da01ddb"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7046-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7046-06", "marketing_start_date": "20180501"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7046-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7046-61", "marketing_start_date": "20180501"}], "brand_name": "HYDROXYCHLOROQUINE SULFATE", "product_id": "0904-7046_a0a69116-862a-4dfa-820f-33e95343edfe", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "0904-7046", "generic_name": "HYDROXYCHLOROQUINE SULFATE", "labeler_name": "Major Pharmaceuticals", "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": "20180501", "listing_expiration_date": "20261231"}