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
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
TORRENT PHARMACEUTICALS LIMITED

Identifiers & Regulatory

Product NDC 13668-721
Product ID 13668-721_4580eab3-3229-1af6-e063-6394a90af35c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207626
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

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 13668721
Hyphenated Format 13668-721

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0313668723052 0313668723106 0313668720105 0313668721058 0313668721904 0313668722055 0313668722901 0313668722109 0313668721102
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 ANDA207626 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (13668-721-05)
  • 1000 TABLET in 1 BOTTLE (13668-721-10)
  • 90 TABLET in 1 BOTTLE (13668-721-90)
source: ndc

Packages (3)

13668-721-05 500 TABLET in 1 BOTTLE (13668-721-05) 13668-721-10 1000 TABLET in 1 BOTTLE (13668-721-10) 13668-721-90 90 TABLET in 1 BOTTLE (13668-721-90)

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": "4580eab3-3229-1af6-e063-6394a90af35c", "openfda": {"upc": ["0313668723052", "0313668723106", "0313668720105", "0313668721058", "0313668721904", "0313668722055", "0313668722901", "0313668722109", "0313668721102"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["6985e729-d963-4f32-89a1-727472b86daa"], "manufacturer_name": ["TORRENT PHARMACEUTICALS LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-721-05)", "package_ndc": "13668-721-05", "marketing_start_date": "20230801"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13668-721-10)", "package_ndc": "13668-721-10", "marketing_start_date": "20241220"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (13668-721-90)", "package_ndc": "13668-721-90", "marketing_start_date": "20230801"}], "brand_name": "Rosuvastatin Calcium", "product_id": "13668-721_4580eab3-3229-1af6-e063-6394a90af35c", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "13668-721", "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": "ANDA207626", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}