atorvastatin calcium

Generic: atorvastatin calcium

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 20 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-045
Product ID 16729-045_40828d2e-69eb-5d38-e063-6394a90abd70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207687
Listing Expiration 2026-12-31
Marketing Start 2018-08-06

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 16729045
Hyphenated Format 16729-045

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 ANDA207687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (16729-045-15)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16729-045-17)
source: ndc

Packages (2)

16729-045-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-045-15) 16729-045-17 1000 TABLET, FILM COATED in 1 BOTTLE (16729-045-17)

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": "40828d2e-69eb-5d38-e063-6394a90abd70", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["4e06b20d-cc5d-46eb-991b-5972248de3af"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16729-045-15)", "package_ndc": "16729-045-15", "marketing_start_date": "20210713"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-045-17)", "package_ndc": "16729-045-17", "marketing_start_date": "20180806"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "16729-045_40828d2e-69eb-5d38-e063-6394a90abd70", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16729-045", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA207687", "marketing_category": "ANDA", "marketing_start_date": "20180806", "listing_expiration_date": "20261231"}