atorvastatin calcium

Generic: atorvastatin calcium

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-251
Product ID 68382-251_20ce0005-b8e5-41e1-b224-9d15f13484b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206536
Marketing Start 2018-11-21
Marketing End 2026-04-01

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 68382251
Hyphenated Format 68382-251

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
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 ANDA206536 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-251-01)
  • 500 TABLET in 1 BOTTLE (68382-251-05)
  • 30 TABLET in 1 BOTTLE (68382-251-06)
  • 1000 TABLET in 1 BOTTLE (68382-251-10)
  • 90 TABLET in 1 BOTTLE (68382-251-16)
  • 10 BLISTER PACK in 1 CARTON (68382-251-77) / 10 TABLET in 1 BLISTER PACK (68382-251-30)
source: ndc

Packages (6)

68382-251-01 100 TABLET in 1 BOTTLE (68382-251-01) 68382-251-05 500 TABLET in 1 BOTTLE (68382-251-05) 68382-251-06 30 TABLET in 1 BOTTLE (68382-251-06) 68382-251-10 1000 TABLET in 1 BOTTLE (68382-251-10) 68382-251-16 90 TABLET in 1 BOTTLE (68382-251-16) 68382-251-77 10 BLISTER PACK in 1 CARTON (68382-251-77) / 10 TABLET in 1 BLISTER PACK (68382-251-30)

Ingredients (1)

atorvastatin calcium trihydrate (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": "20ce0005-b8e5-41e1-b224-9d15f13484b0", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["f99b0839-28dd-4e77-b920-570af6843052"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-251-01)", "package_ndc": "68382-251-01", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-251-05)", "package_ndc": "68382-251-05", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-251-06)", "package_ndc": "68382-251-06", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-251-10)", "package_ndc": "68382-251-10", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-251-16)", "package_ndc": "68382-251-16", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-251-77)  / 10 TABLET in 1 BLISTER PACK (68382-251-30)", "package_ndc": "68382-251-77", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}], "brand_name": "atorvastatin calcium", "product_id": "68382-251_20ce0005-b8e5-41e1-b224-9d15f13484b0", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68382-251", "generic_name": "atorvastatin calcium", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA206536", "marketing_category": "ANDA", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}