pitavastatin calcium

Generic: pitavastatin

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

Drug Facts

Product Profile

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

pitavastatin calcium 1 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-5055
Product ID 0378-5055_44bb6612-917c-4457-952a-5751ea607867
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206070
Listing Expiration 2026-12-31
Marketing Start 2023-11-02

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 03785055
Hyphenated Format 0378-5055

Supplemental Identifiers

RxCUI
861643 861648 861652
UPC
0303785057772 0303785056775 0303785055778
UNII
IYD54XEG3W

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 pitavastatin calcium (source: ndc)
Generic Name pitavastatin (source: ndc)
Application Number ANDA206070 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77)
source: ndc

Packages (1)

0378-5055-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77)

Ingredients (1)

pitavastatin calcium (1 mg/1)

Linked Drug Pages (1)

Pitavastatin Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44bb6612-917c-4457-952a-5751ea607867", "openfda": {"upc": ["0303785057772", "0303785056775", "0303785055778"], "unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["26b5e5e8-45cd-4a98-9af4-2d04c1130881"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77)", "package_ndc": "0378-5055-77", "marketing_start_date": "20231102"}], "brand_name": "Pitavastatin Calcium", "product_id": "0378-5055_44bb6612-917c-4457-952a-5751ea607867", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0378-5055", "generic_name": "pitavastatin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pitavastatin Calcium", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "1 mg/1"}], "application_number": "ANDA206070", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}