atorvastatin calcium

Generic: atorvastatin calcium

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium propylene glycol solvate 40 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8008
Product ID 0615-8008_8763121c-ceae-4ce3-87fc-91909d586ac9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090548
Listing Expiration 2026-12-31
Marketing Start 2012-05-29

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 06158008
Hyphenated Format 0615-8008

Supplemental Identifiers

RxCUI
617311
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
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-05)
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-07)
  • 14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-14)
  • 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-28)
  • 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8008-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-39)
source: ndc

Packages (6)

0615-8008-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-05) 0615-8008-07 7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-07) 0615-8008-14 14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-14) 0615-8008-28 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-28) 0615-8008-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8008-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK 0615-8008-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-39)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (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": "8763121c-ceae-4ce3-87fc-91909d586ac9", "openfda": {"unii": ["YRZ789OWMI"], "rxcui": ["617311"], "spl_set_id": ["40e6b63f-0a20-404a-8915-2f698877a96b"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-05)", "package_ndc": "0615-8008-05", "marketing_start_date": "20181106"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-07)", "package_ndc": "0615-8008-07", "marketing_start_date": "20181106"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-14)", "package_ndc": "0615-8008-14", "marketing_start_date": "20221213"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-28)", "package_ndc": "0615-8008-28", "marketing_start_date": "20240416"}, {"sample": false, "description": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8008-30)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0615-8008-30", "marketing_start_date": "20181112"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-39)", "package_ndc": "0615-8008-39", "marketing_start_date": "20181106"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "0615-8008_8763121c-ceae-4ce3-87fc-91909d586ac9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0615-8008", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE", "strength": "40 mg/1"}], "application_number": "ANDA090548", "marketing_category": "ANDA", "marketing_start_date": "20120529", "listing_expiration_date": "20261231"}