rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-078
Product ID 71205-078_300f3b11-59d4-4065-8bfb-e48494bbc407
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 71205078
Hyphenated Format 71205-078

Supplemental Identifiers

RxCUI
859419
UNII
83MVU38M7Q

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
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-078-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-078-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-078-90)
source: ndc

Packages (3)

71205-078-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-078-30) 71205-078-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-078-60) 71205-078-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-078-90)

Ingredients (1)

rosuvastatin calcium (40 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": "300f3b11-59d4-4065-8bfb-e48494bbc407", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419"], "spl_set_id": ["a9478b12-89d2-42a4-a310-707a87ef43d7"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-078-30)", "package_ndc": "71205-078-30", "marketing_start_date": "20180801"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-078-60)", "package_ndc": "71205-078-60", "marketing_start_date": "20180801"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-078-90)", "package_ndc": "71205-078-90", "marketing_start_date": "20180801"}], "brand_name": "Rosuvastatin Calcium", "product_id": "71205-078_300f3b11-59d4-4065-8bfb-e48494bbc407", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71205-078", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA079170", "marketing_category": "ANDA", "marketing_start_date": "20160719", "listing_expiration_date": "20261231"}