atorvastatin calcium

Generic: atorvastatin calcium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-609
Product ID 59651-609_b9128b7d-1e45-4f05-9f0a-26bd825e402d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217118
Listing Expiration 2027-12-31
Marketing Start 2024-02-13

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 59651609
Hyphenated Format 59651-609

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0359651607909
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 ANDA217118 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (59651-609-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (59651-609-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (59651-609-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (59651-609-99)
source: ndc

Packages (4)

59651-609-05 500 TABLET, FILM COATED in 1 BOTTLE (59651-609-05) 59651-609-30 30 TABLET, FILM COATED in 1 BOTTLE (59651-609-30) 59651-609-90 90 TABLET, FILM COATED in 1 BOTTLE (59651-609-90) 59651-609-99 1000 TABLET, FILM COATED in 1 BOTTLE (59651-609-99)

Ingredients (1)

atorvastatin calcium trihydrate (80 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": "b9128b7d-1e45-4f05-9f0a-26bd825e402d", "openfda": {"upc": ["0359651607909"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["536b5e0d-1bb9-4c9d-a588-460d7647308b"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (59651-609-05)", "package_ndc": "59651-609-05", "marketing_start_date": "20240213"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59651-609-30)", "package_ndc": "59651-609-30", "marketing_start_date": "20240213"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (59651-609-90)", "package_ndc": "59651-609-90", "marketing_start_date": "20240213"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (59651-609-99)", "package_ndc": "59651-609-99", "marketing_start_date": "20240213"}], "brand_name": "Atorvastatin Calcium", "product_id": "59651-609_b9128b7d-1e45-4f05-9f0a-26bd825e402d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "59651-609", "generic_name": "Atorvastatin Calcium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA217118", "marketing_category": "ANDA", "marketing_start_date": "20240213", "listing_expiration_date": "20271231"}