rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-583
Product ID 47335-583_1fa645cf-c870-4b0b-b6b3-53c2f1c32a6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079169
Listing Expiration 2026-12-31
Marketing Start 2021-03-01

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 47335583
Hyphenated Format 47335-583

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0347335584813 0347335585810 0347335582819 0347335583816
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 ANDA079169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-583-18)
  • 90 TABLET, FILM COATED in 1 BOTTLE (47335-583-81)
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-583-83)
source: ndc

Packages (3)

47335-583-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-583-18) 47335-583-81 90 TABLET, FILM COATED in 1 BOTTLE (47335-583-81) 47335-583-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-583-83)

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": "1fa645cf-c870-4b0b-b6b3-53c2f1c32a6f", "openfda": {"upc": ["0347335584813", "0347335585810", "0347335582819", "0347335583816"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["ef243da2-d388-40e4-a1cb-a5e0688efc49"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-583-18)", "package_ndc": "47335-583-18", "marketing_start_date": "20210301"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (47335-583-81)", "package_ndc": "47335-583-81", "marketing_start_date": "20210301"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-583-83)", "package_ndc": "47335-583-83", "marketing_start_date": "20230623"}], "brand_name": "Rosuvastatin Calcium", "product_id": "47335-583_1fa645cf-c870-4b0b-b6b3-53c2f1c32a6f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "47335-583", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA079169", "marketing_category": "ANDA", "marketing_start_date": "20210301", "listing_expiration_date": "20261231"}