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 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8574
Product ID 68788-8574_77075b2f-d10f-4fbf-bfae-ab5971aa6c4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216436
Listing Expiration 2026-12-31
Marketing Start 2024-01-26

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 687888574
Hyphenated Format 68788-8574

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 (source: ndc)
Application Number ANDA216436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8574-9)
source: ndc

Packages (1)

68788-8574-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8574-9)

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": "77075b2f-d10f-4fbf-bfae-ab5971aa6c4b", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617311"], "spl_set_id": ["2d9cb8d9-b367-464d-9bcd-6de8de2b6c23"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8574-9)", "package_ndc": "68788-8574-9", "marketing_start_date": "20240126"}], "brand_name": "Atorvastatin Calcium", "product_id": "68788-8574_77075b2f-d10f-4fbf-bfae-ab5971aa6c4b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8574", "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": "40 mg/1"}], "application_number": "ANDA216436", "marketing_category": "ANDA", "marketing_start_date": "20240126", "listing_expiration_date": "20261231"}