atorvastatin calcium

Generic: atorvastatin calcium

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1593
Product ID 67046-1593_3eee2d70-e7f6-05a7-e063-6394a90a7514
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217081
Listing Expiration 2026-12-31
Marketing Start 2025-09-16

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 670461593
Hyphenated Format 67046-1593

Supplemental Identifiers

RxCUI
259255
UNII
48A5M73Z4Q

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 ANDA217081 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1593-3)
source: ndc

Packages (1)

67046-1593-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1593-3)

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": "3eee2d70-e7f6-05a7-e063-6394a90a7514", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255"], "spl_set_id": ["3eee2ddb-851e-15ad-e063-6394a90a173a"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1593-3)", "package_ndc": "67046-1593-3", "marketing_start_date": "20250916"}], "brand_name": "Atorvastatin calcium", "product_id": "67046-1593_3eee2d70-e7f6-05a7-e063-6394a90a7514", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "67046-1593", "generic_name": "Atorvastatin calcium", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA217081", "marketing_category": "ANDA", "marketing_start_date": "20250916", "listing_expiration_date": "20261231"}