rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8535
Product ID 0615-8535_9feb1012-a261-4a00-a854-26cff1a6f517
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 06158535
Hyphenated Format 0615-8535

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
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 BLISTER PACK (0615-8535-39)
source: ndc

Packages (1)

0615-8535-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8535-39)

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": "9feb1012-a261-4a00-a854-26cff1a6f517", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["d84f596d-8b99-419c-9a02-4b5e26aeaea8"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8535-39)", "package_ndc": "0615-8535-39", "marketing_start_date": "20240918"}], "brand_name": "Rosuvastatin Calcium", "product_id": "0615-8535_9feb1012-a261-4a00-a854-26cff1a6f517", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0615-8535", "generic_name": "Rosuvastatin Calcium", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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"}