rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: cranbury pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler cranbury pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 20 mg/1

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-157
Product ID 27808-157_6c4547c4-9429-42e5-998f-e97f6a74f150
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207408
Listing Expiration 2026-12-31
Marketing Start 2018-01-08

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 27808157
Hyphenated Format 27808-157

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0327808157027 0327808155030 0327808158017 0327808156013 0327808155023 0327808157034 0327808156037 0327808156020 0327808157010 0327808158031 0327808158024 0327808155016
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 ANDA207408 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (27808-157-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (27808-157-02)
  • 500 TABLET, FILM COATED in 1 BOTTLE (27808-157-03)
source: ndc

Packages (3)

27808-157-01 90 TABLET, FILM COATED in 1 BOTTLE (27808-157-01) 27808-157-02 1000 TABLET, FILM COATED in 1 BOTTLE (27808-157-02) 27808-157-03 500 TABLET, FILM COATED in 1 BOTTLE (27808-157-03)

Ingredients (1)

rosuvastatin calcium (20 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": "6c4547c4-9429-42e5-998f-e97f6a74f150", "openfda": {"upc": ["0327808157027", "0327808155030", "0327808158017", "0327808156013", "0327808155023", "0327808157034", "0327808156037", "0327808156020", "0327808157010", "0327808158031", "0327808158024", "0327808155016"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["606d16fb-82e4-420d-9456-09997562b528"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (27808-157-01)", "package_ndc": "27808-157-01", "marketing_start_date": "20180108"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (27808-157-02)", "package_ndc": "27808-157-02", "marketing_start_date": "20250501"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (27808-157-03)", "package_ndc": "27808-157-03", "marketing_start_date": "20190726"}], "brand_name": "Rosuvastatin Calcium", "product_id": "27808-157_6c4547c4-9429-42e5-998f-e97f6a74f150", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "27808-157", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Cranbury Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "20 mg/1"}], "application_number": "ANDA207408", "marketing_category": "ANDA", "marketing_start_date": "20180108", "listing_expiration_date": "20261231"}