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 80 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-036
Product ID 71610-036_b294ecc8-3293-48a9-b79f-58ed5969ff43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205519
Listing Expiration 2026-12-31
Marketing Start 2017-11-16

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 71610036
Hyphenated Format 71610-036

Supplemental Identifiers

RxCUI
259255
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
  • 80 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-036-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-036-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-036-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-036-60)
source: ndc

Packages (4)

71610-036-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-036-15) 71610-036-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-036-30) 71610-036-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-036-45) 71610-036-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-036-60)

Ingredients (1)

atorvastatin calcium trihydrate (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": "b294ecc8-3293-48a9-b79f-58ed5969ff43", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255"], "spl_set_id": ["b16b3805-7e60-447c-b3df-7a9392b63c99"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-036-15)", "package_ndc": "71610-036-15", "marketing_start_date": "20180126"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-036-30)", "package_ndc": "71610-036-30", "marketing_start_date": "20180126"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-036-45)", "package_ndc": "71610-036-45", "marketing_start_date": "20180126"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-036-60)", "package_ndc": "71610-036-60", "marketing_start_date": "20180131"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "71610-036_b294ecc8-3293-48a9-b79f-58ed5969ff43", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-036", "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": "80 mg/1"}], "application_number": "ANDA205519", "marketing_category": "ANDA", "marketing_start_date": "20171116", "listing_expiration_date": "20261231"}