atorvastatin calcium

Generic: atorvastatin calcium

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5057
Product ID 0093-5057_3186764b-e45b-4748-9582-ed2ad77193d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205300
Listing Expiration 2026-12-31
Marketing Start 2017-05-04

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 00935057
Hyphenated Format 0093-5057

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
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 ANDA205300 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (0093-5057-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (0093-5057-98)
source: ndc

Packages (2)

0093-5057-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-5057-05) 0093-5057-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-5057-98)

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": "3186764b-e45b-4748-9582-ed2ad77193d5", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["86841382-4229-4e03-958e-3ac22639efd4"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0093-5057-05)", "package_ndc": "0093-5057-05", "marketing_start_date": "20220523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0093-5057-98)", "package_ndc": "0093-5057-98", "marketing_start_date": "20170504"}], "brand_name": "Atorvastatin Calcium", "product_id": "0093-5057_3186764b-e45b-4748-9582-ed2ad77193d5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0093-5057", "generic_name": "Atorvastatin Calcium", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA205300", "marketing_category": "ANDA", "marketing_start_date": "20170504", "listing_expiration_date": "20261231"}