hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: creekwood pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler creekwood pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 200 mg/1

Manufacturer
Creekwood Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 82619-131
Product ID 82619-131_40b93dff-c062-433c-e063-6294a90a6b67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040150
Listing Expiration 2026-12-31
Marketing Start 2025-05-08

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82619131
Hyphenated Format 82619-131

Supplemental Identifiers

RxCUI
979092
UPC
0382619131017 0382619131024 0382619131031
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 ANDA040150 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82619-131-01)
  • 500 TABLET in 1 BOTTLE (82619-131-02)
  • 1000 TABLET in 1 BOTTLE (82619-131-03)
source: ndc

Packages (3)

82619-131-01 100 TABLET in 1 BOTTLE (82619-131-01) 82619-131-02 500 TABLET in 1 BOTTLE (82619-131-02) 82619-131-03 1000 TABLET in 1 BOTTLE (82619-131-03)

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": "40b93dff-c062-433c-e063-6294a90a6b67", "openfda": {"upc": ["0382619131017", "0382619131024", "0382619131031"], "unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["04139607-f7c0-4fe1-a210-ffa5af347d56"], "manufacturer_name": ["Creekwood Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82619-131-01)", "package_ndc": "82619-131-01", "marketing_start_date": "20250508"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (82619-131-02)", "package_ndc": "82619-131-02", "marketing_start_date": "20250508"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82619-131-03)", "package_ndc": "82619-131-03", "marketing_start_date": "20250508"}], "brand_name": "HYDROXYCHLOROQUINE SULFATE", "product_id": "82619-131_40b93dff-c062-433c-e063-6294a90a6b67", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "82619-131", "generic_name": "hydroxychloroquine sulfate", "labeler_name": "Creekwood Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYCHLOROQUINE SULFATE", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA040150", "marketing_category": "ANDA", "marketing_start_date": "20250508", "listing_expiration_date": "20261231"}