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 propylene glycol solvate 80 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-633
Product ID 71610-633_24733c5a-94ea-400b-8e16-62cf696802b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090548
Listing Expiration 2026-12-31
Marketing Start 2021-08-01

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 71610633
Hyphenated Format 71610-633

Supplemental Identifiers

RxCUI
259255
UNII
YRZ789OWMI

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 ANDA090548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-633-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-633-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-633-60)
source: ndc

Packages (4)

71610-633-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-633-15) 71610-633-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30) 71610-633-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-633-45) 71610-633-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-633-60)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (80 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": "24733c5a-94ea-400b-8e16-62cf696802b1", "openfda": {"unii": ["YRZ789OWMI"], "rxcui": ["259255"], "spl_set_id": ["2b7fbe2a-1f7a-4944-b589-87ca05af7481"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-633-15)", "package_ndc": "71610-633-15", "marketing_start_date": "20220207"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30)", "package_ndc": "71610-633-30", "marketing_start_date": "20220207"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-633-45)", "package_ndc": "71610-633-45", "marketing_start_date": "20220207"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-633-60)", "package_ndc": "71610-633-60", "marketing_start_date": "20220207"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "71610-633_24733c5a-94ea-400b-8e16-62cf696802b1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-633", "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 PROPYLENE GLYCOL SOLVATE", "strength": "80 mg/1"}], "application_number": "ANDA090548", "marketing_category": "ANDA", "marketing_start_date": "20210801", "listing_expiration_date": "20261231"}