atorvastatin calcium

Generic: atorvastatin calcium

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 20 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-023
Product ID 72205-023_11823aa6-547f-4c0b-983a-65b837f94e89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211933
Listing Expiration 2026-12-31
Marketing Start 2019-02-08

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 72205023
Hyphenated Format 72205-023

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0372205025905 0372205025059 0372205024052
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 ANDA211933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72205-023-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72205-023-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72205-023-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72205-023-99)
source: ndc

Packages (4)

72205-023-05 500 TABLET, FILM COATED in 1 BOTTLE (72205-023-05) 72205-023-30 30 TABLET, FILM COATED in 1 BOTTLE (72205-023-30) 72205-023-90 90 TABLET, FILM COATED in 1 BOTTLE (72205-023-90) 72205-023-99 1000 TABLET, FILM COATED in 1 BOTTLE (72205-023-99)

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": "11823aa6-547f-4c0b-983a-65b837f94e89", "openfda": {"upc": ["0372205025905", "0372205025059", "0372205024052"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["bc448f40-421c-490f-8c39-fa8135507973"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72205-023-05)", "package_ndc": "72205-023-05", "marketing_start_date": "20190208"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72205-023-30)", "package_ndc": "72205-023-30", "marketing_start_date": "20190208"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72205-023-90)", "package_ndc": "72205-023-90", "marketing_start_date": "20190208"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72205-023-99)", "package_ndc": "72205-023-99", "marketing_start_date": "20210719"}], "brand_name": "Atorvastatin calcium", "product_id": "72205-023_11823aa6-547f-4c0b-983a-65b837f94e89", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72205-023", "generic_name": "Atorvastatin calcium", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA211933", "marketing_category": "ANDA", "marketing_start_date": "20190208", "listing_expiration_date": "20261231"}