atorvastatin calcium

Generic: atorvastatin calcium

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atorvastatin 40 mg/1

Manufacturer
NIVAGEN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 75834-257
Product ID 75834-257_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 75834257
Hyphenated Format 75834-257

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
  • 40 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (75834-257-01)
  • 2500 TABLET in 1 BOTTLE (75834-257-25)
  • 500 TABLET in 1 BOTTLE (75834-257-50)
  • 90 TABLET in 1 BOTTLE (75834-257-90)
source: ndc

Packages (4)

75834-257-01 1000 TABLET in 1 BOTTLE (75834-257-01) 75834-257-25 2500 TABLET in 1 BOTTLE (75834-257-25) 75834-257-50 500 TABLET in 1 BOTTLE (75834-257-50) 75834-257-90 90 TABLET in 1 BOTTLE (75834-257-90)

Ingredients (1)

atorvastatin (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": "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 (75834-257-01)", "package_ndc": "75834-257-01", "marketing_start_date": "20200826"}, {"sample": false, "description": "2500 TABLET in 1 BOTTLE (75834-257-25)", "package_ndc": "75834-257-25", "marketing_start_date": "20200826"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (75834-257-50)", "package_ndc": "75834-257-50", "marketing_start_date": "20200826"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (75834-257-90)", "package_ndc": "75834-257-90", "marketing_start_date": "20200826"}], "brand_name": "Atorvastatin calcium", "product_id": "75834-257_4580fe3c-b524-3a14-e063-6294a90a34d3", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "75834-257", "generic_name": "Atorvastatin calcium", "labeler_name": "NIVAGEN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA213853", "marketing_category": "ANDA", "marketing_start_date": "20200826", "listing_expiration_date": "20261231"}