rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: shandong new time pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rosuvastatin calcium 10 mg/1

Manufacturer
Shandong New Time Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 42677-302
Product ID 42677-302_47b31d1c-f321-11d2-e063-6294a90af883
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207375
Listing Expiration 2027-12-31
Marketing Start 2022-01-22

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 42677302
Hyphenated Format 42677-302

Supplemental Identifiers

RxCUI
859424 859747
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 ANDA207375 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-02)
source: ndc

Packages (2)

42677-302-01 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-01) 42677-302-02 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-02)

Ingredients (1)

rosuvastatin calcium (10 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": "47b31d1c-f321-11d2-e063-6294a90af883", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859424", "859747"], "spl_set_id": ["ce767751-696f-4750-8438-a276ae999137"], "manufacturer_name": ["Shandong New Time Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-01)", "package_ndc": "42677-302-01", "marketing_start_date": "20220122"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-02)", "package_ndc": "42677-302-02", "marketing_start_date": "20220122"}], "brand_name": "Rosuvastatin Calcium", "product_id": "42677-302_47b31d1c-f321-11d2-e063-6294a90af883", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "42677-302", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Shandong New Time Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA207375", "marketing_category": "ANDA", "marketing_start_date": "20220122", "listing_expiration_date": "20271231"}