hydroxychloroquine sulfate

Generic: hydroxychloroquine sulfate

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxychloroquine sulfate 200 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3955
Product ID 68071-3955_49023444-f693-b9c9-e063-6294a90a2fc9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040657
Listing Expiration 2027-12-31
Marketing Start 2019-10-01

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713955
Hyphenated Format 68071-3955

Supplemental Identifiers

RxCUI
979092
UPC
0368071395563
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 ANDA040657 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (68071-3955-6)
source: ndc

Packages (1)

68071-3955-6 60 TABLET, FILM COATED in 1 BOTTLE (68071-3955-6)

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": "49023444-f693-b9c9-e063-6294a90a2fc9", "openfda": {"upc": ["0368071395563"], "unii": ["8Q2869CNVH"], "rxcui": ["979092"], "spl_set_id": ["4902343c-7d1b-ba70-e063-6294a90a3680"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68071-3955-6)", "package_ndc": "68071-3955-6", "marketing_start_date": "20260122"}], "brand_name": "Hydroxychloroquine sulfate", "product_id": "68071-3955_49023444-f693-b9c9-e063-6294a90a2fc9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "68071-3955", "generic_name": "Hydroxychloroquine sulfate", "labeler_name": "NuCare Pharmaceuticals, 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": "20191001", "listing_expiration_date": "20271231"}