rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-989
Product ID 16714-989_af3a6349-8b25-462d-9fbf-3e95c32734df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079172
Listing Expiration 2026-12-31
Marketing Start 2019-06-27

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 16714989
Hyphenated Format 16714-989

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0316714990019 0316714988016 0316714989013 0316714991016
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 ANDA079172 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (16714-989-01)
source: ndc

Packages (1)

16714-989-01 90 TABLET, FILM COATED in 1 BOTTLE (16714-989-01)

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": "af3a6349-8b25-462d-9fbf-3e95c32734df", "openfda": {"upc": ["0316714990019", "0316714988016", "0316714989013", "0316714991016"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["17d71c80-fade-4735-acec-60738d26dd01"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16714-989-01)", "package_ndc": "16714-989-01", "marketing_start_date": "20190627"}], "brand_name": "Rosuvastatin Calcium", "product_id": "16714-989_af3a6349-8b25-462d-9fbf-3e95c32734df", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16714-989", "generic_name": "Rosuvastatin Calcium", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA079172", "marketing_category": "ANDA", "marketing_start_date": "20190627", "listing_expiration_date": "20261231"}