atorvastatin calcium

Generic: atorvastatin calcium

Labeler: cipla usa inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Cipla USA Inc.,

Identifiers & Regulatory

Product NDC 69097-947
Product ID 69097-947_ee5777b3-1606-4a9c-b761-211b47d28522
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205519
Listing Expiration 2026-12-31
Marketing Start 2017-11-16

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 69097947
Hyphenated Format 69097-947

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
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
  • 90 TABLET, FILM COATED in 1 BOTTLE (69097-947-05)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69097-947-12)
source: ndc

Packages (2)

69097-947-05 90 TABLET, FILM COATED in 1 BOTTLE (69097-947-05) 69097-947-12 500 TABLET, FILM COATED in 1 BOTTLE (69097-947-12)

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": "ee5777b3-1606-4a9c-b761-211b47d28522", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["18fe5990-399d-416c-852f-e14974317b8b"], "manufacturer_name": ["Cipla USA Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (69097-947-05)", "package_ndc": "69097-947-05", "marketing_start_date": "20171116"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69097-947-12)", "package_ndc": "69097-947-12", "marketing_start_date": "20171116"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "69097-947_ee5777b3-1606-4a9c-b761-211b47d28522", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "69097-947", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Cipla USA 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": "20171116", "listing_expiration_date": "20261231"}