atorvastatin calcium

Generic: atorvastatin calcium

Labeler: lepu pharmaceutical technology co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler lepu pharmaceutical technology co., ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Lepu Pharmaceutical Technology Co., Ltd.

Identifiers & Regulatory

Product NDC 82137-018
Product ID 82137-018_4257c559-499e-3a38-e063-6394a90aa0c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216848
Listing Expiration 2026-12-31
Marketing Start 2022-11-01

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 82137018
Hyphenated Format 82137-018

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0382137016018 0382137018012 0382137017015 0382137019019
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 ANDA216848 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (82137-018-01)
source: ndc

Packages (1)

82137-018-01 90 TABLET, FILM COATED in 1 BOTTLE (82137-018-01)

Ingredients (1)

atorvastatin calcium trihydrate (40 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": "4257c559-499e-3a38-e063-6394a90aa0c9", "openfda": {"upc": ["0382137016018", "0382137018012", "0382137017015", "0382137019019"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["173474b6-26b4-46f2-a12a-64753ae5e905"], "manufacturer_name": ["Lepu Pharmaceutical Technology Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82137-018-01)", "package_ndc": "82137-018-01", "marketing_start_date": "20221101"}], "brand_name": "atorvastatin calcium", "product_id": "82137-018_4257c559-499e-3a38-e063-6394a90aa0c9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "82137-018", "generic_name": "atorvastatin calcium", "labeler_name": "Lepu Pharmaceutical Technology Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA216848", "marketing_category": "ANDA", "marketing_start_date": "20221101", "listing_expiration_date": "20261231"}