atorvastatin calcium

Generic: atorvastatin calcium

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-513
Product ID 67877-513_777b866a-796a-4d15-8cb6-dd0c9a1856e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209288
Listing Expiration 2026-12-31
Marketing Start 2018-12-23

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 67877513
Hyphenated Format 67877-513

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0367877512051 0367877513102 0367877514109
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 ANDA209288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-513-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (67877-513-10)
  • 2000 TABLET, FILM COATED in 1 BOTTLE (67877-513-23)
  • 10 BLISTER PACK in 1 CARTON (67877-513-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-513-33)
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-513-90)
source: ndc

Packages (5)

67877-513-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-513-05) 67877-513-10 1000 TABLET, FILM COATED in 1 BOTTLE (67877-513-10) 67877-513-23 2000 TABLET, FILM COATED in 1 BOTTLE (67877-513-23) 67877-513-38 10 BLISTER PACK in 1 CARTON (67877-513-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-513-33) 67877-513-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-513-90)

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": "777b866a-796a-4d15-8cb6-dd0c9a1856e2", "openfda": {"upc": ["0367877512051", "0367877513102", "0367877514109"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["67e60880-091a-4df7-8696-6e6c42a490e2"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-513-05)", "package_ndc": "67877-513-05", "marketing_start_date": "20181223"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (67877-513-10)", "package_ndc": "67877-513-10", "marketing_start_date": "20181223"}, {"sample": false, "description": "2000 TABLET, FILM COATED in 1 BOTTLE (67877-513-23)", "package_ndc": "67877-513-23", "marketing_start_date": "20181223"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-513-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-513-33)", "package_ndc": "67877-513-38", "marketing_start_date": "20181223"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-513-90)", "package_ndc": "67877-513-90", "marketing_start_date": "20181223"}], "brand_name": "Atorvastatin Calcium", "product_id": "67877-513_777b866a-796a-4d15-8cb6-dd0c9a1856e2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "67877-513", "generic_name": "Atorvastatin Calcium", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA209288", "marketing_category": "ANDA", "marketing_start_date": "20181223", "listing_expiration_date": "20261231"}