rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rosuvastatin calcium 5 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-043
Product ID 71209-043_e931da38-899a-4efb-9d6c-42e3a6a1b56f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207453
Listing Expiration 2027-12-31
Marketing Start 2017-03-24

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 71209043
Hyphenated Format 71209-043

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0371209045049 0371209046015 0371209044042 0371209043045
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 ANDA207453 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (71209-043-04)
source: ndc

Packages (1)

71209-043-04 90 TABLET, FILM COATED in 1 BOTTLE (71209-043-04)

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": "e931da38-899a-4efb-9d6c-42e3a6a1b56f", "openfda": {"upc": ["0371209045049", "0371209046015", "0371209044042", "0371209043045"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["6802a946-a29c-4d41-997b-3c078ed8e74d"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71209-043-04)", "package_ndc": "71209-043-04", "marketing_start_date": "20181121"}], "brand_name": "Rosuvastatin Calcium", "product_id": "71209-043_e931da38-899a-4efb-9d6c-42e3a6a1b56f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71209-043", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA207453", "marketing_category": "ANDA", "marketing_start_date": "20170324", "listing_expiration_date": "20271231"}