atorvastatin calcium

Generic: atorvastatin calcium, film coated

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8887
Product ID 68788-8887_7fc58ce3-f069-409b-b36f-bb23ce21fb6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209912
Listing Expiration 2026-12-31
Marketing Start 2025-09-23

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 687888887
Hyphenated Format 68788-8887

Supplemental Identifiers

RxCUI
617311
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, film coated (source: ndc)
Application Number ANDA209912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8887-1)
  • 30 TABLET in 1 BOTTLE (68788-8887-3)
  • 60 TABLET in 1 BOTTLE (68788-8887-6)
  • 90 TABLET in 1 BOTTLE (68788-8887-9)
source: ndc

Packages (4)

68788-8887-1 100 TABLET in 1 BOTTLE (68788-8887-1) 68788-8887-3 30 TABLET in 1 BOTTLE (68788-8887-3) 68788-8887-6 60 TABLET in 1 BOTTLE (68788-8887-6) 68788-8887-9 90 TABLET in 1 BOTTLE (68788-8887-9)

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": "7fc58ce3-f069-409b-b36f-bb23ce21fb6f", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617311"], "spl_set_id": ["7fc58ce3-f069-409b-b36f-bb23ce21fb6f"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8887-1)", "package_ndc": "68788-8887-1", "marketing_start_date": "20250923"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8887-3)", "package_ndc": "68788-8887-3", "marketing_start_date": "20250923"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8887-6)", "package_ndc": "68788-8887-6", "marketing_start_date": "20250923"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8887-9)", "package_ndc": "68788-8887-9", "marketing_start_date": "20250923"}], "brand_name": "Atorvastatin Calcium", "product_id": "68788-8887_7fc58ce3-f069-409b-b36f-bb23ce21fb6f", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8887", "generic_name": "atorvastatin calcium, film coated", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA209912", "marketing_category": "ANDA", "marketing_start_date": "20250923", "listing_expiration_date": "20261231"}