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 trihydrate 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4422
Product ID 70518-4422_3e7739d5-0d9b-6d91-e063-6394a90a77b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217081
Listing Expiration 2026-12-31
Marketing Start 2025-08-04

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 705184422
Hyphenated Format 70518-4422

Supplemental Identifiers

RxCUI
617312
UNII
48A5M73Z4Q

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 ANDA217081 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4422-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-2)
source: ndc

Packages (3)

70518-4422-0 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-0) 70518-4422-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4422-1) 70518-4422-2 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-2)

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": "3e7739d5-0d9b-6d91-e063-6394a90a77b7", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617312"], "spl_set_id": ["f7bb4aac-f716-4dd9-a6d7-6f37e865b843"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-0)", "package_ndc": "70518-4422-0", "marketing_start_date": "20250804"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4422-1)", "package_ndc": "70518-4422-1", "marketing_start_date": "20250821"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-2)", "package_ndc": "70518-4422-2", "marketing_start_date": "20250910"}], "brand_name": "Atorvastatin calcium", "product_id": "70518-4422_3e7739d5-0d9b-6d91-e063-6394a90a77b7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-4422", "generic_name": "Atorvastatin calcium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA217081", "marketing_category": "ANDA", "marketing_start_date": "20250804", "listing_expiration_date": "20261231"}