rosuvastatin

Generic: rosuvastatin

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

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-264
Product ID 33342-264_d7b9f280-bda6-40d4-9778-e45efb87ab23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207296
Listing Expiration 2026-12-31
Marketing Start 2024-11-06

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 33342264
Hyphenated Format 33342-264

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0333342261441
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 (source: ndc)
Generic Name rosuvastatin (source: ndc)
Application Number ANDA207296 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 CONTAINER (33342-264-07)
  • 90 TABLET in 1 CONTAINER (33342-264-10)
  • 10 BLISTER PACK in 1 CARTON (33342-264-12) / 10 TABLET in 1 BLISTER PACK
  • 1000 TABLET in 1 CONTAINER (33342-264-44)
source: ndc

Packages (4)

33342-264-07 30 TABLET in 1 CONTAINER (33342-264-07) 33342-264-10 90 TABLET in 1 CONTAINER (33342-264-10) 33342-264-12 10 BLISTER PACK in 1 CARTON (33342-264-12) / 10 TABLET in 1 BLISTER PACK 33342-264-44 1000 TABLET in 1 CONTAINER (33342-264-44)

Ingredients (1)

rosuvastatin calcium (40 mg/1)

Linked Drug Pages (1)

Rosuvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7b9f280-bda6-40d4-9778-e45efb87ab23", "openfda": {"upc": ["0333342261441"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["d7b9f280-bda6-40d4-9778-e45efb87ab23"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 CONTAINER (33342-264-07)", "package_ndc": "33342-264-07", "marketing_start_date": "20241106"}, {"sample": false, "description": "90 TABLET in 1 CONTAINER (33342-264-10)", "package_ndc": "33342-264-10", "marketing_start_date": "20241106"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-264-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-264-12", "marketing_start_date": "20241106"}, {"sample": false, "description": "1000 TABLET in 1 CONTAINER (33342-264-44)", "package_ndc": "33342-264-44", "marketing_start_date": "20241106"}], "brand_name": "Rosuvastatin", "product_id": "33342-264_d7b9f280-bda6-40d4-9778-e45efb87ab23", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "33342-264", "generic_name": "Rosuvastatin", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA207296", "marketing_category": "ANDA", "marketing_start_date": "20241106", "listing_expiration_date": "20261231"}