rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-168
Product ID 57237-168_20865c19-8939-458b-b3db-d38f3fb00bed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079170
Listing Expiration 2026-12-31
Marketing Start 2016-07-19

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 57237168
Hyphenated Format 57237-168

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0357237168905 0357237171905 0357237169902 0357237170908
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 ANDA079170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (57237-168-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (57237-168-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (57237-168-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (57237-168-99)
source: ndc

Packages (4)

57237-168-05 500 TABLET, FILM COATED in 1 BOTTLE (57237-168-05) 57237-168-30 30 TABLET, FILM COATED in 1 BOTTLE (57237-168-30) 57237-168-90 90 TABLET, FILM COATED in 1 BOTTLE (57237-168-90) 57237-168-99 1000 TABLET, FILM COATED in 1 BOTTLE (57237-168-99)

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": "20865c19-8939-458b-b3db-d38f3fb00bed", "openfda": {"upc": ["0357237168905", "0357237171905", "0357237169902", "0357237170908"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["5c992d3d-d754-48b6-a267-1451208352ed"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (57237-168-05)", "package_ndc": "57237-168-05", "marketing_start_date": "20160719"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (57237-168-30)", "package_ndc": "57237-168-30", "marketing_start_date": "20160719"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (57237-168-90)", "package_ndc": "57237-168-90", "marketing_start_date": "20160719"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (57237-168-99)", "package_ndc": "57237-168-99", "marketing_start_date": "20160719"}], "brand_name": "Rosuvastatin Calcium", "product_id": "57237-168_20865c19-8939-458b-b3db-d38f3fb00bed", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "57237-168", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA079170", "marketing_category": "ANDA", "marketing_start_date": "20160719", "listing_expiration_date": "20261231"}