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
Routes
ORAL
Active Ingredients

atorvastatin 20 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8416
Product ID 68788-8416_099797df-9770-438f-be88-102ff080970f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213853
Listing Expiration 2026-12-31
Marketing Start 2023-04-11

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888416
Hyphenated Format 68788-8416

Supplemental Identifiers

RxCUI
617310
UNII
A0JWA85V8F
NUI
N0000175589 N0000000121

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 ANDA213853 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8416-1)
  • 30 TABLET in 1 BOTTLE (68788-8416-3)
  • 60 TABLET in 1 BOTTLE (68788-8416-6)
  • 90 TABLET in 1 BOTTLE (68788-8416-9)
source: ndc

Packages (4)

68788-8416-1 100 TABLET in 1 BOTTLE (68788-8416-1) 68788-8416-3 30 TABLET in 1 BOTTLE (68788-8416-3) 68788-8416-6 60 TABLET in 1 BOTTLE (68788-8416-6) 68788-8416-9 90 TABLET in 1 BOTTLE (68788-8416-9)

Ingredients (1)

atorvastatin (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": "099797df-9770-438f-be88-102ff080970f", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["A0JWA85V8F"], "rxcui": ["617310"], "spl_set_id": ["14d3b7df-d0df-4f1b-abd4-d733be7433a5"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8416-1)", "package_ndc": "68788-8416-1", "marketing_start_date": "20230411"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8416-3)", "package_ndc": "68788-8416-3", "marketing_start_date": "20230411"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8416-6)", "package_ndc": "68788-8416-6", "marketing_start_date": "20230411"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8416-9)", "package_ndc": "68788-8416-9", "marketing_start_date": "20230411"}], "brand_name": "Atorvastatin calcium", "product_id": "68788-8416_099797df-9770-438f-be88-102ff080970f", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8416", "generic_name": "Atorvastatin calcium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA213853", "marketing_category": "ANDA", "marketing_start_date": "20230411", "listing_expiration_date": "20261231"}