atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 10 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-940
Product ID 42385-940_ba8208d7-c3b8-4ddc-8826-9f5265513bfa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214513
Listing Expiration 2026-12-31
Marketing Start 2024-01-23

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 42385940
Hyphenated Format 42385-940

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0342385943306 0342385940305 0342385942309 0342385941302 0342385943085
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 ANDA214513 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42385-940-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42385-940-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42385-940-11)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42385-940-30)
  • 10 BLISTER PACK in 1 CARTON (42385-940-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-940-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90)
source: ndc

Packages (6)

42385-940-01 100 TABLET, FILM COATED in 1 BOTTLE (42385-940-01) 42385-940-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-940-05) 42385-940-11 1000 TABLET, FILM COATED in 1 BOTTLE (42385-940-11) 42385-940-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-940-30) 42385-940-68 10 BLISTER PACK in 1 CARTON (42385-940-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-940-10) 42385-940-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90)

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": "ba8208d7-c3b8-4ddc-8826-9f5265513bfa", "openfda": {"upc": ["0342385943306", "0342385940305", "0342385942309", "0342385941302", "0342385943085"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["9f8ca507-b784-4d18-8d3e-d7d68072c416"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42385-940-01)", "package_ndc": "42385-940-01", "marketing_start_date": "20240123"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42385-940-05)", "package_ndc": "42385-940-05", "marketing_start_date": "20240123"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42385-940-11)", "package_ndc": "42385-940-11", "marketing_start_date": "20240123"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42385-940-30)", "package_ndc": "42385-940-30", "marketing_start_date": "20240123"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42385-940-68)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-940-10)", "package_ndc": "42385-940-68", "marketing_start_date": "20240123"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90)", "package_ndc": "42385-940-90", "marketing_start_date": "20240123"}], "brand_name": "Atorvastatin Calcium", "product_id": "42385-940_ba8208d7-c3b8-4ddc-8826-9f5265513bfa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "42385-940", "generic_name": "Atorvastatin Calcium", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA214513", "marketing_category": "ANDA", "marketing_start_date": "20240123", "listing_expiration_date": "20261231"}