pitavastatin

Generic: pitavastatin calcium

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pitavastatin calcium 2.09 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-906
Product ID 42291-906_48843604-c6e9-1aec-e063-6294a90aea80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205932
Listing Expiration 2027-12-31
Marketing Start 2024-01-16

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 42291906
Hyphenated Format 42291-906

Supplemental Identifiers

RxCUI
861643 861648 861652
UNII
IYD54XEG3W

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 calcium (source: ndc)
Application Number ANDA205932 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.09 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (42291-906-90)
source: ndc

Packages (1)

42291-906-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-906-90)

Ingredients (1)

pitavastatin calcium (2.09 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": "48843604-c6e9-1aec-e063-6294a90aea80", "openfda": {"unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["0f11ee80-871e-4f13-e063-6394a90af19d"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42291-906-90)", "package_ndc": "42291-906-90", "marketing_start_date": "20240116"}], "brand_name": "Pitavastatin", "product_id": "42291-906_48843604-c6e9-1aec-e063-6294a90aea80", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "42291-906", "generic_name": "pitavastatin calcium", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pitavastatin", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "2.09 mg/1"}], "application_number": "ANDA205932", "marketing_category": "ANDA", "marketing_start_date": "20240116", "listing_expiration_date": "20271231"}