pitavastatin calcium

Generic: pitavastatin calcium

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pitavastatin calcium
Generic Name pitavastatin calcium
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pitavastatin calcium 2.09 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-479
Product ID 72603-479_27e1ba97-23bf-fc12-e063-6394a90a1699
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205977
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

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 72603479
Hyphenated Format 72603-479

Supplemental Identifiers

RxCUI
861648 861652
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
  • 2.09 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (72603-479-01)
source: ndc

Packages (1)

72603-479-01 90 TABLET, FILM COATED in 1 BOTTLE (72603-479-01)

Ingredients (1)

pitavastatin calcium (2.09 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": "27e1ba97-23bf-fc12-e063-6394a90a1699", "openfda": {"unii": ["IYD54XEG3W"], "rxcui": ["861648", "861652"], "spl_set_id": ["98e3f1df-5b38-4169-a340-adb145eac459"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72603-479-01)", "package_ndc": "72603-479-01", "marketing_start_date": "20241201"}], "brand_name": "pitavastatin calcium", "product_id": "72603-479_27e1ba97-23bf-fc12-e063-6394a90a1699", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72603-479", "generic_name": "pitavastatin calcium", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pitavastatin calcium", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "2.09 mg/1"}], "application_number": "ANDA205977", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}