pitavastatin

Generic: pitavastatin

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pitavastatin
Generic Name pitavastatin
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pitavastatin calcium 4 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-031
Product ID 65162-031_ab7d1d71-229c-4528-9c2d-59d268c48c25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205961
Listing Expiration 2026-12-31
Marketing Start 2024-08-21

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 65162031
Hyphenated Format 65162-031

Supplemental Identifiers

RxCUI
861643 861648 861652
UPC
0365162030099 0365162031096 0365162029093
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 (source: ndc)
Generic Name pitavastatin (source: ndc)
Application Number ANDA205961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65162-031-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65162-031-09)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65162-031-50)
source: ndc

Packages (3)

65162-031-03 30 TABLET, FILM COATED in 1 BOTTLE (65162-031-03) 65162-031-09 90 TABLET, FILM COATED in 1 BOTTLE (65162-031-09) 65162-031-50 500 TABLET, FILM COATED in 1 BOTTLE (65162-031-50)

Ingredients (1)

pitavastatin calcium (4 mg/1)

Linked Drug Pages (1)

Pitavastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ab7d1d71-229c-4528-9c2d-59d268c48c25", "openfda": {"upc": ["0365162030099", "0365162031096", "0365162029093"], "unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["7fbfcc0c-9251-456d-a525-e62cfd8abd4b"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65162-031-03)", "package_ndc": "65162-031-03", "marketing_start_date": "20240821"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65162-031-09)", "package_ndc": "65162-031-09", "marketing_start_date": "20240821"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65162-031-50)", "package_ndc": "65162-031-50", "marketing_start_date": "20240821"}], "brand_name": "Pitavastatin", "product_id": "65162-031_ab7d1d71-229c-4528-9c2d-59d268c48c25", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "65162-031", "generic_name": "Pitavastatin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pitavastatin", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "4 mg/1"}], "application_number": "ANDA205961", "marketing_category": "ANDA", "marketing_start_date": "20240821", "listing_expiration_date": "20261231"}