zypitamag

Generic: pitavastatin magnesium

Labeler: medicure international inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zypitamag
Generic Name pitavastatin magnesium
Labeler medicure international inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pitavastatin 4 mg/1

Manufacturer
Medicure International Inc

Identifiers & Regulatory

Product NDC 25208-202
Product ID 25208-202_d39ef44a-4e4d-459d-86bd-79394202e3ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208379
Listing Expiration 2026-12-31
Marketing Start 2018-03-09

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25208202
Hyphenated Format 25208-202

Supplemental Identifiers

RxCUI
2001262 2001264 2001266 2001268
UPC
0325208202156 0325208201159
UNII
M5681Q5F9P
NUI
N0000175589 N0000000121

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 zypitamag (source: ndc)
Generic Name pitavastatin magnesium (source: ndc)
Application Number NDA208379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09)
  • 500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15)
source: ndc

Packages (2)

25208-202-09 90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09) 25208-202-15 500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15)

Ingredients (1)

pitavastatin (4 mg/1)

Linked Drug Pages (1)

ZYPITAMAG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d39ef44a-4e4d-459d-86bd-79394202e3ec", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0325208202156", "0325208201159"], "unii": ["M5681Q5F9P"], "rxcui": ["2001262", "2001264", "2001266", "2001268"], "spl_set_id": ["c8c50e03-5cb8-43f4-bdef-8edd12f1945f"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Medicure International Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09)", "package_ndc": "25208-202-09", "marketing_start_date": "20180309"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15)", "package_ndc": "25208-202-15", "marketing_start_date": "20180309"}], "brand_name": "ZYPITAMAG", "product_id": "25208-202_d39ef44a-4e4d-459d-86bd-79394202e3ec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "25208-202", "generic_name": "Pitavastatin Magnesium", "labeler_name": "Medicure International Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYPITAMAG", "active_ingredients": [{"name": "PITAVASTATIN", "strength": "4 mg/1"}], "application_number": "NDA208379", "marketing_category": "NDA", "marketing_start_date": "20180309", "listing_expiration_date": "20261231"}