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
Routes
ORAL
Active Ingredients

atorvastatin 80 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3848
Product ID 70518-3848_3f8bd7d1-9146-83b0-e063-6394a90aeaa7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213853
Listing Expiration 2026-12-31
Marketing Start 2023-08-31

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183848
Hyphenated Format 70518-3848

Supplemental Identifiers

RxCUI
259255
UNII
A0JWA85V8F
NUI
N0000175589 N0000000121

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 ANDA213853 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3848-0)
  • 100 TABLET in 1 BOTTLE, PLASTIC (70518-3848-2)
source: ndc

Packages (2)

70518-3848-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-3848-0) 70518-3848-2 100 TABLET in 1 BOTTLE, PLASTIC (70518-3848-2)

Ingredients (1)

atorvastatin (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": "3f8bd7d1-9146-83b0-e063-6394a90aeaa7", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["A0JWA85V8F"], "rxcui": ["259255"], "spl_set_id": ["6600f22e-d303-4fe3-8212-accd6fb06e62"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3848-0)", "package_ndc": "70518-3848-0", "marketing_start_date": "20230831"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (70518-3848-2)", "package_ndc": "70518-3848-2", "marketing_start_date": "20250319"}], "brand_name": "Atorvastatin calcium", "product_id": "70518-3848_3f8bd7d1-9146-83b0-e063-6394a90aeaa7", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-3848", "generic_name": "Atorvastatin calcium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin calcium", "active_ingredients": [{"name": "ATORVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA213853", "marketing_category": "ANDA", "marketing_start_date": "20230831", "listing_expiration_date": "20261231"}