pitavastatin

Generic: pitavastatin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pitavastatin
Generic Name pitavastatin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pitavastatin calcium 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-812
Product ID 65862-812_9a71c5a7-aaf8-4650-aba4-da6ba84d03a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206015
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 65862812
Hyphenated Format 65862-812

Supplemental Identifiers

RxCUI
861643 861648 861652
UPC
0365862813909 0365862812902
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 ANDA206015 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90)
source: ndc

Packages (2)

65862-812-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05) 65862-812-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90)

Ingredients (1)

pitavastatin calcium (1 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": "9a71c5a7-aaf8-4650-aba4-da6ba84d03a7", "openfda": {"upc": ["0365862813909", "0365862812902"], "unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["a52401eb-a822-475b-a40d-7b8acde2ae1a"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05)", "package_ndc": "65862-812-05", "marketing_start_date": "20231102"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90)", "package_ndc": "65862-812-90", "marketing_start_date": "20231102"}], "brand_name": "Pitavastatin", "product_id": "65862-812_9a71c5a7-aaf8-4650-aba4-da6ba84d03a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "65862-812", "generic_name": "Pitavastatin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pitavastatin", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "1 mg/1"}], "application_number": "ANDA206015", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}