atorvastatin calcium

Generic: atorvastatin calcium

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler micro labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 10 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-172
Product ID 42571-172_336c8e4f-ccef-2741-e063-6294a90a4520
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205945
Listing Expiration 2026-12-31
Marketing Start 2020-01-01

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 42571172
Hyphenated Format 42571-172

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0342571173906 0342571172909 0342571174903 0342571175900
UNII
48A5M73Z4Q

Packaging Origin

Original Packager
true

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 ANDA205945 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42571-172-10)
  • 10 BLISTER PACK in 1 CARTON (42571-172-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-172-32)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42571-172-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42571-172-90)
source: ndc

Packages (4)

42571-172-10 1000 TABLET, FILM COATED in 1 BOTTLE (42571-172-10) 42571-172-11 10 BLISTER PACK in 1 CARTON (42571-172-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-172-32) 42571-172-30 30 TABLET, FILM COATED in 1 BOTTLE (42571-172-30) 42571-172-90 90 TABLET, FILM COATED in 1 BOTTLE (42571-172-90)

Ingredients (1)

atorvastatin calcium trihydrate (10 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": "336c8e4f-ccef-2741-e063-6294a90a4520", "openfda": {"upc": ["0342571173906", "0342571172909", "0342571174903", "0342571175900"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["2e94161c-3360-4fb0-bb3a-048fdc1d137a"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42571-172-10)", "package_ndc": "42571-172-10", "marketing_start_date": "20200101"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42571-172-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-172-32)", "package_ndc": "42571-172-11", "marketing_start_date": "20200101"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42571-172-30)", "package_ndc": "42571-172-30", "marketing_start_date": "20200101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42571-172-90)", "package_ndc": "42571-172-90", "marketing_start_date": "20200101"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "42571-172_336c8e4f-ccef-2741-e063-6294a90a4520", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "42571-172", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA205945", "marketing_category": "ANDA", "marketing_start_date": "20200101", "listing_expiration_date": "20261231"}