atorvastatin calcium (75834-256)

Drug Facts

Product Profile

Brand Name atorvastatin calcium

Generic Name atorvastatin calcium

Labeler nivagen pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

atorvastatin 20 mg/1

Manufacturer

NIVAGEN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 75834-256

Product ID 75834-256_4580fe3c-b524-3a14-e063-6294a90a34d3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213853

Listing Expiration 2026-12-31

Marketing Start 2020-08-26

Pharmacologic Class

Established (EPC)

hmg-coa reductase inhibitor [epc]

Mechanism of Action

hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834256

Hyphenated Format 75834-256

Supplemental Identifiers

RxCUI

259255 617310 617311 617312

UPC

0375834258027 0375834257501 0375834255903 0375834256016

UNII

A0JWA85V8F

NUI

N0000175589 N0000000121

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 ANDA213853 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

1000 TABLET in 1 BOTTLE (75834-256-01)
5000 TABLET in 1 BOTTLE (75834-256-05)
500 TABLET in 1 BOTTLE (75834-256-50)
90 TABLET in 1 BOTTLE (75834-256-90)

source: ndc

Packages (4)

75834-256-01 1000 TABLET in 1 BOTTLE (75834-256-01) 75834-256-05 5000 TABLET in 1 BOTTLE (75834-256-05) 75834-256-50 500 TABLET in 1 BOTTLE (75834-256-50) 75834-256-90 90 TABLET in 1 BOTTLE (75834-256-90)

Ingredients (1)

atorvastatin (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": "4580fe3c-b524-3a14-e063-6294a90a34d3", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0375834258027", "0375834257501", "0375834255903", "0375834256016"], "unii": ["A0JWA85V8F"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["7c58bf4a-4a92-4db8-89bc-4de1b5831efc"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["NIVAGEN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (75834-256-01)", "package_ndc": "75834-256-01", "marketing_start_date": "20200826"}, {"sample": false, "description": "5000 TABLET in 1 BOTTLE (75834-256-05)", "package_ndc": "75834-256-05", "marketing_start_date": "20200826"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (75834-256-50)", "package_ndc": "75834-256-50", "marketing_start_date": "20200826"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (75834-256-90)", "package_ndc": "75834-256-90", "marketing_start_date": "20200826"}], "brand_name": "Atorvastatin calcium", "product_id": "75834-256_4580fe3c-b524-3a14-e063-6294a90a34d3", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "75834-256", "generic_name": "Atorvastatin calcium", "labeler_name": "NIVAGEN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA213853", "marketing_category": "ANDA", "marketing_start_date": "20200826", "listing_expiration_date": "20261231"}