atorvastatin calcium

Generic: atorvastatin calcium

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3953
Product ID 0378-3953_c94bf799-ec3d-4644-b1a2-3c7b3f612e19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091226
Listing Expiration 2026-12-31
Marketing Start 2013-09-19

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 03783953
Hyphenated Format 0378-3953

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0303783953779 0303783952772 0303783950778 0303783951775
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 ANDA091226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-77)
source: ndc

Packages (2)

0378-3953-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-05) 0378-3953-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-77)

Ingredients (1)

atorvastatin calcium trihydrate (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": "c94bf799-ec3d-4644-b1a2-3c7b3f612e19", "openfda": {"upc": ["0303783953779", "0303783952772", "0303783950778", "0303783951775"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-05)", "package_ndc": "0378-3953-05", "marketing_start_date": "20140214"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-77)", "package_ndc": "0378-3953-77", "marketing_start_date": "20131009"}], "brand_name": "Atorvastatin Calcium", "product_id": "0378-3953_c94bf799-ec3d-4644-b1a2-3c7b3f612e19", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0378-3953", "generic_name": "atorvastatin calcium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA091226", "marketing_category": "ANDA", "marketing_start_date": "20130919", "listing_expiration_date": "20261231"}