rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-180
Product ID 13668-180_56bc6158-e7ab-433e-af24-090c5777e2f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201619
Listing Expiration 2026-12-31
Marketing Start 2016-10-31

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 13668180
Hyphenated Format 13668-180

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0313668179309 0313668181302 0313668180305 0313668182309
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 ANDA201619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, COATED in 1 BOTTLE (13668-180-05)
  • 30 TABLET, COATED in 1 BOTTLE (13668-180-30)
  • 90 TABLET, COATED in 1 BOTTLE (13668-180-90)
source: ndc

Packages (3)

13668-180-05 500 TABLET, COATED in 1 BOTTLE (13668-180-05) 13668-180-30 30 TABLET, COATED in 1 BOTTLE (13668-180-30) 13668-180-90 90 TABLET, COATED in 1 BOTTLE (13668-180-90)

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": "56bc6158-e7ab-433e-af24-090c5777e2f0", "openfda": {"upc": ["0313668179309", "0313668181302", "0313668180305", "0313668182309"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["8c2d481f-53f2-4cf6-bd28-7d92323785cd"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (13668-180-05)", "package_ndc": "13668-180-05", "marketing_start_date": "20161031"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (13668-180-30)", "package_ndc": "13668-180-30", "marketing_start_date": "20161031"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (13668-180-90)", "package_ndc": "13668-180-90", "marketing_start_date": "20161031"}], "brand_name": "Rosuvastatin Calcium", "product_id": "13668-180_56bc6158-e7ab-433e-af24-090c5777e2f0", "dosage_form": "TABLET, COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "13668-180", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA201619", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}