pitavastatin calcium

Generic: pitavastatin calcium

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

Drug Facts

Product Profile

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

pitavastatin calcium 1 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-291
Product ID 72865-291_3fef3397-a028-b301-e063-6394a90a913f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205977
Listing Expiration 2026-12-31
Marketing Start 2025-09-18

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 72865291
Hyphenated Format 72865-291

Supplemental Identifiers

RxCUI
861643 861648 861652
UPC
0372865291900 0372865293904 0372865292907
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 calcium (source: ndc)
Application Number ANDA205977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (72865-291-90)
source: ndc

Packages (1)

72865-291-90 90 TABLET, FILM COATED in 1 BOTTLE (72865-291-90)

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": "3fef3397-a028-b301-e063-6394a90a913f", "openfda": {"upc": ["0372865291900", "0372865293904", "0372865292907"], "unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["f29ea90c-f4e5-4f14-9660-a0404ef87f18"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72865-291-90)", "package_ndc": "72865-291-90", "marketing_start_date": "20250918"}], "brand_name": "pitavastatin calcium", "product_id": "72865-291_3fef3397-a028-b301-e063-6394a90a913f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72865-291", "generic_name": "pitavastatin calcium", "labeler_name": "XLCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pitavastatin calcium", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "1 mg/1"}], "application_number": "ANDA205977", "marketing_category": "ANDA", "marketing_start_date": "20250918", "listing_expiration_date": "20261231"}