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 70518-4138
Product ID 70518-4138_3fb3b563-4bba-0322-e063-6394a90a238d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209288
Listing Expiration 2026-12-31
Marketing Start 2024-07-10

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 705184138
Hyphenated Format 70518-4138

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 ANDA209288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-0)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-1)
source: ndc

Packages (2)

70518-4138-0 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-0) 70518-4138-1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-1)

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": "3fb3b563-4bba-0322-e063-6394a90a238d", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617312"], "spl_set_id": ["57f9b462-f08e-483c-9b64-b7e4c8d46927"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-0)", "package_ndc": "70518-4138-0", "marketing_start_date": "20240710"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-1)", "package_ndc": "70518-4138-1", "marketing_start_date": "20250319"}], "brand_name": "Atorvastatin Calcium", "product_id": "70518-4138_3fb3b563-4bba-0322-e063-6394a90a238d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-4138", "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": "ANDA209288", "marketing_category": "ANDA", "marketing_start_date": "20240710", "listing_expiration_date": "20261231"}