atorvastatin calcium

Generic: atorvastatin calcium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium propylene glycol solvate 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1322
Product ID 70518-1322_48d6a1d8-b643-2332-e063-6294a90af0ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090548
Listing Expiration 2027-12-31
Marketing Start 2018-07-25

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 705181322
Hyphenated Format 70518-1322

Supplemental Identifiers

RxCUI
617311
UNII
YRZ789OWMI

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 ANDA090548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1322-1)
source: ndc

Packages (1)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (40 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "48d6a1d8-b643-2332-e063-6294a90af0ab", "openfda": {"unii": ["YRZ789OWMI"], "rxcui": ["617311"], "spl_set_id": ["303989c9-823e-4bcb-a7b3-7024fd0d3a38"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1322-1)", "package_ndc": "70518-1322-1", "marketing_start_date": "20180725"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "70518-1322_48d6a1d8-b643-2332-e063-6294a90af0ab", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-1322", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE", "strength": "40 mg/1"}], "application_number": "ANDA090548", "marketing_category": "ANDA", "marketing_start_date": "20180725", "listing_expiration_date": "20271231"}