atorvastatin calcium

Generic: atorvastatin calcium

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 10 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-226
Product ID 72189-226_2c283f9f-1dbb-4a4c-e063-6394a90a7953
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076477
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 72189226
Hyphenated Format 72189-226

Supplemental Identifiers

RxCUI
617312
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 ANDA076477 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-226-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-226-90)
source: ndc

Packages (2)

72189-226-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-226-30) 72189-226-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-226-90)

Ingredients (1)

atorvastatin calcium trihydrate (10 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": "2c283f9f-1dbb-4a4c-e063-6394a90a7953", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617312"], "spl_set_id": ["c3b70f79-45a3-0869-e053-2a95a90a3cdb"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-226-30)", "package_ndc": "72189-226-30", "marketing_start_date": "20210601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-226-90)", "package_ndc": "72189-226-90", "marketing_start_date": "20210601"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "72189-226_2c283f9f-1dbb-4a4c-e063-6394a90a7953", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72189-226", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA076477", "marketing_category": "ANDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}