atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 20 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-316
Product ID 33342-316_7bd0f0ec-f7a3-4403-9a1a-11f18213631f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208480
Listing Expiration 2026-12-31
Marketing Start 2024-06-03

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 33342316
Hyphenated Format 33342-316

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0333342316158 0333342316103 0333342315106 0333342317155 0333342318152 0333342315151 0333342318107 0333342317100
UNII
48A5M73Z4Q

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 atorvastatin calcium (source: ndc)
Generic Name atorvastatin calcium (source: ndc)
Application Number ANDA208480 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (33342-316-10)
  • 10 BLISTER PACK in 1 CARTON (33342-316-12) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (33342-316-15)
source: ndc

Packages (3)

33342-316-10 90 TABLET in 1 BOTTLE (33342-316-10) 33342-316-12 10 BLISTER PACK in 1 CARTON (33342-316-12) / 10 TABLET in 1 BLISTER PACK 33342-316-15 500 TABLET in 1 BOTTLE (33342-316-15)

Ingredients (1)

atorvastatin calcium trihydrate (20 mg/1)

Linked Drug Pages (1)

Atorvastatin calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7bd0f0ec-f7a3-4403-9a1a-11f18213631f", "openfda": {"upc": ["0333342316158", "0333342316103", "0333342315106", "0333342317155", "0333342318152", "0333342315151", "0333342318107", "0333342317100"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["7bd0f0ec-f7a3-4403-9a1a-11f18213631f"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-316-10)", "package_ndc": "33342-316-10", "marketing_start_date": "20240603"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-316-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-316-12", "marketing_start_date": "20240603"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-316-15)", "package_ndc": "33342-316-15", "marketing_start_date": "20240603"}], "brand_name": "Atorvastatin calcium", "product_id": "33342-316_7bd0f0ec-f7a3-4403-9a1a-11f18213631f", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "33342-316", "generic_name": "Atorvastatin calcium", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA208480", "marketing_category": "ANDA", "marketing_start_date": "20240603", "listing_expiration_date": "20261231"}