MedPath

Atorvastatin Calcium

Approved
Approval ID

2881210e-b0d8-44a1-8540-d7cb985b89b9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 28, 2014

Manufacturers
FDA

Northwind Pharmaceuticals

DUNS: 036986393

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Atorvastatin Calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51655-880
Application NumberANDA020702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atorvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2014
FDA Product Classification

INGREDIENTS (1)

ATORVASTATIN CALCIUMActive
Quantity: 80 mg in 30 1
Code: 48A5M73Z4Q
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Atorvastatin Calcium - FDA Drug Approval Details