atorvastatin calcium

Generic: atorvastatin calcium

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1446
Product ID 70771-1446_17e443c1-adcb-436d-9a25-99b0a31163ce
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 707711446
Hyphenated Format 70771-1446

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
  • 80 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1446-0)
  • 100 TABLET in 1 BOTTLE (70771-1446-1)
  • 30 TABLET in 1 BOTTLE (70771-1446-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1446-4) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (70771-1446-5)
  • 90 TABLET in 1 BOTTLE (70771-1446-9)
source: ndc

Packages (6)

70771-1446-0 1000 TABLET in 1 BOTTLE (70771-1446-0) 70771-1446-1 100 TABLET in 1 BOTTLE (70771-1446-1) 70771-1446-3 30 TABLET in 1 BOTTLE (70771-1446-3) 70771-1446-4 10 BLISTER PACK in 1 CARTON (70771-1446-4) / 10 TABLET in 1 BLISTER PACK 70771-1446-5 500 TABLET in 1 BOTTLE (70771-1446-5) 70771-1446-9 90 TABLET in 1 BOTTLE (70771-1446-9)

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": "17e443c1-adcb-436d-9a25-99b0a31163ce", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["cda119f2-54c8-4a08-b266-a0dbd214d2ce"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1446-0)", "package_ndc": "70771-1446-0", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1446-1)", "package_ndc": "70771-1446-1", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1446-3)", "package_ndc": "70771-1446-3", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1446-4)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70771-1446-4", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1446-5)", "package_ndc": "70771-1446-5", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70771-1446-9)", "package_ndc": "70771-1446-9", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}], "brand_name": "atorvastatin calcium", "product_id": "70771-1446_17e443c1-adcb-436d-9a25-99b0a31163ce", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70771-1446", "generic_name": "atorvastatin calcium", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA206536", "marketing_category": "ANDA", "marketing_end_date": "20260401", "marketing_start_date": "20181121"}