rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: zhejiang yongtai pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler zhejiang yongtai pharmaceutical co., ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Zhejiang Yongtai Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 69434-005
Product ID 69434-005_457bc8b2-1eca-69c2-e063-6294a90a7ba1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212059
Listing Expiration 2026-12-31
Marketing Start 2025-03-02

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 69434005
Hyphenated Format 69434-005

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0369434006027 0369434008014
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 calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA212059 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-02)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-03)
source: ndc

Packages (2)

69434-005-02 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-02) 69434-005-03 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-03)

Ingredients (1)

rosuvastatin calcium (5 mg/1)

Linked Drug Pages (1)

Rosuvastatin Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "457bc8b2-1eca-69c2-e063-6294a90a7ba1", "openfda": {"upc": ["0369434006027", "0369434008014"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["40c2900e-4659-49ce-ba4b-5df529b3c53b"], "manufacturer_name": ["Zhejiang Yongtai Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-02)", "package_ndc": "69434-005-02", "marketing_start_date": "20250302"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-03)", "package_ndc": "69434-005-03", "marketing_start_date": "20250302"}], "brand_name": "Rosuvastatin Calcium", "product_id": "69434-005_457bc8b2-1eca-69c2-e063-6294a90a7ba1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "69434-005", "generic_name": "rosuvastatin calcium", "labeler_name": "Zhejiang Yongtai Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA212059", "marketing_category": "ANDA", "marketing_start_date": "20250302", "listing_expiration_date": "20261231"}