pitavastatin calcium

Generic: pitavastatin calcium

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pitavastatin calcium
Generic Name pitavastatin calcium
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pitavastatin calcium 4 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-483
Product ID 68382-483_f34ff300-0613-4b94-9fcf-475d6494ea7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206047
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 68382483
Hyphenated Format 68382-483

Supplemental Identifiers

RxCUI
861643 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 ANDA206047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (68382-483-16)
source: ndc

Packages (1)

68382-483-16 90 TABLET in 1 BOTTLE (68382-483-16)

Ingredients (1)

pitavastatin calcium (4 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": "f34ff300-0613-4b94-9fcf-475d6494ea7e", "openfda": {"unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["c35e747e-10ac-4a76-bce6-187618fc64f9"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-483-16)", "package_ndc": "68382-483-16", "marketing_start_date": "20231102"}], "brand_name": "pitavastatin calcium", "product_id": "68382-483_f34ff300-0613-4b94-9fcf-475d6494ea7e", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68382-483", "generic_name": "pitavastatin calcium", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pitavastatin calcium", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "4 mg/1"}], "application_number": "ANDA206047", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}