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 300 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-805
Product ID 70954-805_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 70954805
Hyphenated Format 70954-805

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
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70954-805-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE (70954-805-20)
source: ndc

Packages (2)

70954-805-10 100 TABLET, FILM COATED in 1 BOTTLE (70954-805-10) 70954-805-20 14 TABLET, FILM COATED in 1 BOTTLE (70954-805-20)

Ingredients (1)

hydroxychloroquine sulfate (300 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": "100 TABLET, FILM COATED in 1 BOTTLE (70954-805-10)", "package_ndc": "70954-805-10", "marketing_start_date": "20230915"}, {"sample": true, "description": "14 TABLET, FILM COATED in 1 BOTTLE (70954-805-20)", "package_ndc": "70954-805-20", "marketing_start_date": "20230915"}], "brand_name": "SOVUNA", "product_id": "70954-805_f8c163b7-15a0-424d-b53d-05fb400948bf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antirheumatic Agent [EPC]"], "product_ndc": "70954-805", "generic_name": "Hydroxychloroquine Sulfate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOVUNA", "active_ingredients": [{"name": "HYDROXYCHLOROQUINE SULFATE", "strength": "300 mg/1"}], "application_number": "NDA214581", "marketing_category": "NDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}