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 20 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1775
Product ID 70710-1775_223716b7-8d87-4704-a08f-799e2cb5c29e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206536
Listing Expiration 2026-12-31
Marketing Start 2024-06-12

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 707101775
Hyphenated Format 70710-1775

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0370710177096 0370710177591
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
  • 20 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70710-1775-0)
  • 500 TABLET in 1 BOTTLE (70710-1775-5)
  • 90 TABLET in 1 BOTTLE (70710-1775-9)
source: ndc

Packages (3)

70710-1775-0 1000 TABLET in 1 BOTTLE (70710-1775-0) 70710-1775-5 500 TABLET in 1 BOTTLE (70710-1775-5) 70710-1775-9 90 TABLET in 1 BOTTLE (70710-1775-9)

Ingredients (1)

atorvastatin calcium trihydrate (20 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": "223716b7-8d87-4704-a08f-799e2cb5c29e", "openfda": {"upc": ["0370710177096", "0370710177591"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["55ad4a90-d177-4cce-b7ec-cb75067f6c14"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70710-1775-0)", "package_ndc": "70710-1775-0", "marketing_start_date": "20240612"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70710-1775-5)", "package_ndc": "70710-1775-5", "marketing_start_date": "20240612"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70710-1775-9)", "package_ndc": "70710-1775-9", "marketing_start_date": "20240612"}], "brand_name": "atorvastatin calcium", "product_id": "70710-1775_223716b7-8d87-4704-a08f-799e2cb5c29e", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70710-1775", "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": "20 mg/1"}], "application_number": "ANDA206536", "marketing_category": "ANDA", "marketing_start_date": "20240612", "listing_expiration_date": "20261231"}