atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Radha Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 77771-454
Product ID 77771-454_253fa5ef-8739-ff93-e063-6394a90adcde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205519
Listing Expiration 2026-12-31
Marketing Start 2023-08-10

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 77771454
Hyphenated Format 77771-454

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0377771453909 0377771452056 0377771452902 0377771453107 0377771454050 0377771451905 0377771451103
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 ANDA205519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (77771-454-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (77771-454-90)
source: ndc

Packages (2)

77771-454-05 500 TABLET, FILM COATED in 1 BOTTLE (77771-454-05) 77771-454-90 90 TABLET, FILM COATED in 1 BOTTLE (77771-454-90)

Ingredients (1)

atorvastatin calcium trihydrate (80 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": "253fa5ef-8739-ff93-e063-6394a90adcde", "openfda": {"upc": ["0377771453909", "0377771452056", "0377771452902", "0377771453107", "0377771454050", "0377771451905", "0377771451103"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["10e766cc-c3fd-4584-a0d7-652c516e828c"], "manufacturer_name": ["Radha Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (77771-454-05)", "package_ndc": "77771-454-05", "marketing_start_date": "20230810"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (77771-454-90)", "package_ndc": "77771-454-90", "marketing_start_date": "20230810"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "77771-454_253fa5ef-8739-ff93-e063-6394a90adcde", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "77771-454", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Radha Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA205519", "marketing_category": "ANDA", "marketing_start_date": "20230810", "listing_expiration_date": "20261231"}