atorvastatin calcium

Generic: atorvastatin calcium

Labeler: safecor health, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler safecor health, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Safecor Health, LLC

Identifiers & Regulatory

Product NDC 48433-009
Product ID 48433-009_4b986c57-fa32-4b7e-e063-6294a90a50a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091226
Listing Expiration 2027-12-31
Marketing Start 2026-02-03

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 48433009
Hyphenated Format 48433-009

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 ANDA091226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (48433-009-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-009-01)
source: ndc

Packages (1)

48433-009-20 100 BLISTER PACK in 1 CARTON (48433-009-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-009-01)

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": "4b986c57-fa32-4b7e-e063-6294a90a50a3", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf"], "manufacturer_name": ["Safecor Health, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (48433-009-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-009-01)", "package_ndc": "48433-009-20", "marketing_start_date": "20260203"}], "brand_name": "Atorvastatin Calcium", "product_id": "48433-009_4b986c57-fa32-4b7e-e063-6294a90a50a3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "48433-009", "generic_name": "atorvastatin calcium", "labeler_name": "Safecor Health, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA091226", "marketing_category": "ANDA", "marketing_start_date": "20260203", "listing_expiration_date": "20271231"}