pitavastatin

Generic: pitavastatin calcium

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

Drug Facts

Product Profile

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

pitavastatin calcium 4.18 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3633
Product ID 0480-3633_191b4856-1662-a7b8-e063-6394a90a2c56
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205932
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 04803633
Hyphenated Format 0480-3633

Supplemental Identifiers

RxCUI
861643 861648 861652
UPC
0304803633985 0304803631981 0304803632988
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 calcium (source: ndc)
Application Number ANDA205932 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4.18 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (0480-3633-98)
source: ndc

Packages (1)

0480-3633-98 90 TABLET, FILM COATED in 1 BOTTLE (0480-3633-98)

Ingredients (1)

pitavastatin calcium (4.18 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": "191b4856-1662-a7b8-e063-6394a90a2c56", "openfda": {"upc": ["0304803633985", "0304803631981", "0304803632988"], "unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["fac09182-dcf2-1770-e053-6394a90af50c"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0480-3633-98)", "package_ndc": "0480-3633-98", "marketing_start_date": "20231102"}], "brand_name": "Pitavastatin", "product_id": "0480-3633_191b4856-1662-a7b8-e063-6394a90a2c56", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0480-3633", "generic_name": "pitavastatin calcium", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pitavastatin", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "4.18 mg/1"}], "application_number": "ANDA205932", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}