rosuvastatin

Generic: rosuvastatin

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

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-285
Product ID 16729-285_4390ed19-e509-95ab-e063-6294a90a2b08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206434
Listing Expiration 2026-12-31
Marketing Start 2016-10-31

Pharmacologic Class

Classes
hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729285
Hyphenated Format 16729-285

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UNII
83MVU38M7Q

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 rosuvastatin (source: ndc)
Generic Name rosuvastatin (source: ndc)
Application Number ANDA206434 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (16729-285-15)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16729-285-17)
source: ndc

Packages (2)

16729-285-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-285-15) 16729-285-17 1000 TABLET, FILM COATED in 1 BOTTLE (16729-285-17)

Ingredients (1)

rosuvastatin calcium (10 mg/1)

Linked Drug Pages (1)

Rosuvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4390ed19-e509-95ab-e063-6294a90a2b08", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["3ffe0294-3997-2755-e054-00144ff8d46c"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16729-285-15)", "package_ndc": "16729-285-15", "marketing_start_date": "20161031"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-285-17)", "package_ndc": "16729-285-17", "marketing_start_date": "20161031"}], "brand_name": "Rosuvastatin", "product_id": "16729-285_4390ed19-e509-95ab-e063-6294a90a2b08", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16729-285", "generic_name": "Rosuvastatin", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA206434", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}