rosuvastatin calcium (65862-295)

Drug Facts

Product Profile

Brand Name rosuvastatin calcium

Generic Name rosuvastatin calcium

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

rosuvastatin calcium 20 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-295

Product ID 65862-295_d170e87b-de05-4fc4-8e53-9367615e77f1

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 65862295

Hyphenated Format 65862-295

Supplemental Identifiers

RxCUI

859419 859424 859747 859751

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 ANDA079170 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED in 1 BOTTLE (65862-295-05)
10 BLISTER PACK in 1 CARTON (65862-295-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
30 TABLET, FILM COATED in 1 BOTTLE (65862-295-30)
90 TABLET, FILM COATED in 1 BOTTLE (65862-295-90)
1000 TABLET, FILM COATED in 1 BOTTLE (65862-295-99)

source: ndc

Packages (5)

65862-295-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-295-05) 65862-295-06 10 BLISTER PACK in 1 CARTON (65862-295-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK 65862-295-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-295-30) 65862-295-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-295-90) 65862-295-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-295-99)

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": "d170e87b-de05-4fc4-8e53-9367615e77f1", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["47924917-bbd5-45de-96cb-c7ff9754da97"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-295-05)", "package_ndc": "65862-295-05", "marketing_start_date": "20160719"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-295-06)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-295-06", "marketing_start_date": "20160719"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-295-30)", "package_ndc": "65862-295-30", "marketing_start_date": "20160719"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-295-90)", "package_ndc": "65862-295-90", "marketing_start_date": "20160719"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-295-99)", "package_ndc": "65862-295-99", "marketing_start_date": "20160719"}], "brand_name": "Rosuvastatin Calcium", "product_id": "65862-295_d170e87b-de05-4fc4-8e53-9367615e77f1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "65862-295", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "20 mg/1"}], "application_number": "ANDA079170", "marketing_category": "ANDA", "marketing_start_date": "20160719", "listing_expiration_date": "20261231"}