hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: accord healthcare, inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxychloroquine sulfate
Generic Name hydroxychloroquine sulfate
Labeler accord healthcare, inc.,
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxychloroquine sulfate 400 mg/1

Manufacturer
Accord Healthcare, Inc.,

Identifiers & Regulatory

Product NDC 16729-563
Product ID 16729-563_415f9dea-bd9e-b05c-e063-6394a90ab7fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213342
Listing Expiration 2026-12-31
Marketing Start 2021-09-28

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729563
Hyphenated Format 16729-563

Supplemental Identifiers

RxCUI
979092 1119312 2569281 2569283
UPC
0316729561013
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 ANDA213342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16729-563-01)
source: ndc

Packages (1)

16729-563-01 100 TABLET in 1 BOTTLE (16729-563-01)

Ingredients (1)

hydroxychloroquine sulfate (400 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": "415f9dea-bd9e-b05c-e063-6394a90ab7fd", "openfda": {"upc": ["0316729561013"], "unii": ["8Q2869CNVH"], "rxcui": ["979092", "1119312", "2569281", "2569283"], "spl_set_id": ["84b00366-96ef-41e1-bac6-5d24acdb9e1d"], "manufacturer_name": ["Accord Healthcare, Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16729-563-01)", "package_ndc": "16729-563-01", "marketing_start_date": "20210928"}], "brand_name": "Hydroxychloroquine Sulfate", "product_id": "16729-563_415f9dea-bd9e-b05c-e063-6394a90ab7fd", "dosage_form": "TABLET", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "16729-563", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "Accord Healthcare, Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxychloroquine Sulfate", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "400 mg/1"}], "application_number": "ANDA213342", "marketing_category": "ANDA", "marketing_start_date": "20210928", "listing_expiration_date": "20261231"}