atorvastatin calcium

Generic: atorvastatin calcium

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-744
Product ID 71610-744_5866cff8-7c35-4050-a75f-5e235b9d39b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205519
Listing Expiration 2026-12-31
Marketing Start 2023-08-10

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 71610744
Hyphenated Format 71610-744

Supplemental Identifiers

RxCUI
259255 617310 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 ANDA205519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-744-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-744-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-744-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-744-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-744-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71610-744-70)
source: ndc

Packages (6)

71610-744-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-744-15) 71610-744-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-744-30) 71610-744-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-744-45) 71610-744-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-744-53) 71610-744-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-744-60) 71610-744-70 120 TABLET, FILM COATED in 1 BOTTLE (71610-744-70)

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": "5866cff8-7c35-4050-a75f-5e235b9d39b2", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311"], "spl_set_id": ["3dbeae00-89ab-48a6-9e57-8048facb2294"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-744-15)", "package_ndc": "71610-744-15", "marketing_start_date": "20231024"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-744-30)", "package_ndc": "71610-744-30", "marketing_start_date": "20231024"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-744-45)", "package_ndc": "71610-744-45", "marketing_start_date": "20231024"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-744-53)", "package_ndc": "71610-744-53", "marketing_start_date": "20231024"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-744-60)", "package_ndc": "71610-744-60", "marketing_start_date": "20231024"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71610-744-70)", "package_ndc": "71610-744-70", "marketing_start_date": "20231024"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "71610-744_5866cff8-7c35-4050-a75f-5e235b9d39b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-744", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA205519", "marketing_category": "ANDA", "marketing_start_date": "20230810", "listing_expiration_date": "20261231"}