atorvastatin calcium (68180-635)

Drug Facts

Product Profile

Brand Name atorvastatin calcium

Generic Name atorvastatin calcium

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

atorvastatin calcium trihydrate 10 mg/1

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-635

Product ID 68180-635_ab716c10-785b-4d43-a5f0-59f95b0b78c8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204991

Listing Expiration 2026-12-31

Marketing Start 2020-09-24

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 68180635

Hyphenated Format 68180-635

Supplemental Identifiers

RxCUI

259255 617310 617311 617312

UNII

48A5M73Z4Q

Packaging Origin

Original Packager

true

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 ANDA204991 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING 10 mg tablets (10 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A16" on the other side. NDC 68180-635-06 bottles of 30 NDC 68180-635-09 bottles of 90 NDC 68180-635-02 bottles of 500 20 mg tablets (20 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A17" on the other side. NDC 68180-636-06 bottles of 30 NDC 68180-636-09 bottles of 90 NDC 68180-636-02 bottles of 500 40 mg tablets (40 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A18" on the other side. NDC 68180-637-06 bottles of 30 NDC 68180-637-09 bottles of 90 NDC 68180-637-02 bottles of 500 80 mg tablets (80 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A19" on the other side. NDC 68180-638-06 bottles of 30 NDC 68180-638-09 bottles of 90 NDC 68180-638-02 bottles of 500 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL ATORVASTATIN CALCIUM TABLETS, USP Rx Only 10 mg NDC 68180-635-06 30 TABLETS ATORVASTATIN CALCIUM TABLETS, USP Rx Only 20 mg NDC 68180-636-06 30 TABLETS ATORVASTATIN CALCIUM TABLETS, USP Rx Only 40 mg NDC 68180-637-06 30 TABLETS ATORVASTATIN CALCIUM TABLETS, USP Rx Only 80 mg NDC 68180-638-06 30 TABLETS 05 06 06 07

source: label

Packages (0)

No package records.

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": "ab716c10-785b-4d43-a5f0-59f95b0b78c8", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["a5767370-15a2-45e5-b980-7af9523aea7b"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Atorvastatin Calcium", "product_id": "68180-635_ab716c10-785b-4d43-a5f0-59f95b0b78c8", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68180-635", "generic_name": "Atorvastatin Calcium", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA204991", "marketing_category": "ANDA", "marketing_start_date": "20200924", "listing_expiration_date": "20261231"}