atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 20 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8683
Product ID 68788-8683_4b8d6845-ea90-4607-8650-e482cc26a5e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214344
Listing Expiration 2027-12-31
Marketing Start 2024-06-01

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 687888683
Hyphenated Format 68788-8683

Supplemental Identifiers

RxCUI
617310 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 ANDA214344 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8683-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8683-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8683-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8683-9)
source: ndc

Packages (4)

68788-8683-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8683-1) 68788-8683-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8683-3) 68788-8683-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8683-6) 68788-8683-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8683-9)

Ingredients (1)

atorvastatin calcium trihydrate (20 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": "4b8d6845-ea90-4607-8650-e482cc26a5e1", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617310", "617312"], "spl_set_id": ["5327cf20-81e0-4b46-8c86-88c0ddd19c5f"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8683-1)", "package_ndc": "68788-8683-1", "marketing_start_date": "20240601"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8683-3)", "package_ndc": "68788-8683-3", "marketing_start_date": "20240601"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8683-6)", "package_ndc": "68788-8683-6", "marketing_start_date": "20240601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8683-9)", "package_ndc": "68788-8683-9", "marketing_start_date": "20240601"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "68788-8683_4b8d6845-ea90-4607-8650-e482cc26a5e1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8683", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA214344", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20271231"}