atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-946
Product ID 76420-946_352ed2e2-c7bd-ae21-e063-6394a90ad835
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 76420946
Hyphenated Format 76420-946

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UNII
48A5M73Z4Q

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
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76420-946-00)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76420-946-05)
  • 120 TABLET, FILM COATED in 1 BOTTLE (76420-946-12)
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-946-20)
  • 2000 TABLET, FILM COATED in 1 BOTTLE (76420-946-23)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-946-30)
  • 10 BLISTER PACK in 1 CARTON (76420-946-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-946-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-946-90)
source: ndc

Packages (9)

76420-946-00 1000 TABLET, FILM COATED in 1 BOTTLE (76420-946-00) 76420-946-05 500 TABLET, FILM COATED in 1 BOTTLE (76420-946-05) 76420-946-12 120 TABLET, FILM COATED in 1 BOTTLE (76420-946-12) 76420-946-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-946-20) 76420-946-23 2000 TABLET, FILM COATED in 1 BOTTLE (76420-946-23) 76420-946-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-946-30) 76420-946-38 10 BLISTER PACK in 1 CARTON (76420-946-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK 76420-946-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-946-60) 76420-946-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-946-90)

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": "352ed2e2-c7bd-ae21-e063-6394a90ad835", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["60d51f39-8086-4434-affe-88ab8ca0c7e5"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76420-946-00)", "package_ndc": "76420-946-00", "marketing_start_date": "20250408"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76420-946-05)", "package_ndc": "76420-946-05", "marketing_start_date": "20250408"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (76420-946-12)", "package_ndc": "76420-946-12", "marketing_start_date": "20250408"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-946-20)", "package_ndc": "76420-946-20", "marketing_start_date": "20250408"}, {"sample": false, "description": "2000 TABLET, FILM COATED in 1 BOTTLE (76420-946-23)", "package_ndc": "76420-946-23", "marketing_start_date": "20250408"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-946-30)", "package_ndc": "76420-946-30", "marketing_start_date": "20250408"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (76420-946-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "76420-946-38", "marketing_start_date": "20250408"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-946-60)", "package_ndc": "76420-946-60", "marketing_start_date": "20250408"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-946-90)", "package_ndc": "76420-946-90", "marketing_start_date": "20250408"}], "brand_name": "Atorvastatin Calcium", "product_id": "76420-946_352ed2e2-c7bd-ae21-e063-6394a90ad835", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "76420-946", "generic_name": "Atorvastatin Calcium", "labeler_name": "Asclemed USA, Inc.", "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"}