sovuna

Generic: hydroxychloroquine sulfate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

hydroxychloroquine sulfate 200 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-804
Product ID 70954-804_f8c163b7-15a0-424d-b53d-05fb400948bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214581
Listing Expiration 2026-12-31
Marketing Start 2023-09-15

Pharmacologic Class

Classes
antimalarial [epc] antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954804
Hyphenated Format 70954-804

Supplemental Identifiers

RxCUI
979092 2569283 2665282 2665284
UPC
0370954805106 0370954804208 0370954804109
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 sovuna (source: ndc)
Generic Name hydroxychloroquine sulfate (source: ndc)
Application Number NDA214581 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10)
  • 100 TABLET, FILM COATED in 1 BOTTLE (70954-804-20)
  • 14 TABLET, FILM COATED in 1 BOTTLE (70954-804-30)
source: ndc

Packages (3)

70954-804-10 30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10) 70954-804-20 100 TABLET, FILM COATED in 1 BOTTLE (70954-804-20) 70954-804-30 14 TABLET, FILM COATED in 1 BOTTLE (70954-804-30)

Ingredients (1)

hydroxychloroquine sulfate (200 mg/1)

Linked Drug Pages (1)

SOVUNA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f8c163b7-15a0-424d-b53d-05fb400948bf", "openfda": {"upc": ["0370954805106", "0370954804208", "0370954804109"], "unii": ["8Q2869CNVH"], "rxcui": ["979092", "2569283", "2665282", "2665284"], "spl_set_id": ["dd441154-b196-4d4c-bc56-2e37f345ef8d"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10)", "package_ndc": "70954-804-10", "marketing_start_date": "20230915"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70954-804-20)", "package_ndc": "70954-804-20", "marketing_start_date": "20230915"}, {"sample": true, "description": "14 TABLET, FILM COATED in 1 BOTTLE (70954-804-30)", "package_ndc": "70954-804-30", "marketing_start_date": "20230915"}], "brand_name": "SOVUNA", "product_id": "70954-804_f8c163b7-15a0-424d-b53d-05fb400948bf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "70954-804", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOVUNA", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "200 mg/1"}], "application_number": "NDA214581", "marketing_category": "NDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}