pitavastatin

Generic: pitavastatin calcium

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pitavastatin
Generic Name pitavastatin calcium
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pitavastatin calcium 1 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6048
Product ID 0832-6048_266944ba-7e94-48c6-e063-6394a90adc2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205955
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 08326048
Hyphenated Format 0832-6048

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 (source: ndc)
Generic Name pitavastatin calcium (source: ndc)
Application Number ANDA205955 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (0832-6048-90)
source: ndc

Packages (1)

0832-6048-90 90 TABLET in 1 BOTTLE (0832-6048-90)

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": "266944ba-7e94-48c6-e063-6394a90adc2e", "openfda": {"unii": ["IYD54XEG3W"], "rxcui": ["861643", "861648", "861652"], "spl_set_id": ["9ad1ecb9-822d-47c1-9f6f-6f771fa0f924"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (0832-6048-90)", "package_ndc": "0832-6048-90", "marketing_start_date": "20231102"}], "brand_name": "Pitavastatin", "product_id": "0832-6048_266944ba-7e94-48c6-e063-6394a90adc2e", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0832-6048", "generic_name": "Pitavastatin Calcium", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pitavastatin", "active_ingredients": [{"name": "PITAVASTATIN CALCIUM", "strength": "1 mg/1"}], "application_number": "ANDA205955", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}