Home NDC 25208-201-12 ZYPITAMAG
Product NDC 25208-201
Requested package NDC 25208-201-12
11-digit product format 252080201
Labeler code 25208
Product ID 25208-201_d39ef44a-4e4d-459d-86bd-79394202e3ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pitavastatin Magnesium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Medicure International Inc
Application NDA208379
Marketing category NDA
Marketing start 2018-03-09
Substance PITAVASTATIN
Active strength 2 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208379-001 ZYPITAMAG PITAVASTATIN MAGNESIUM EQ 1MG BASE TABLET / ORAL RLD 2017-07-14 N208379-002 ZYPITAMAG PITAVASTATIN MAGNESIUM EQ 2MG BASE TABLET / ORAL RLD 2017-07-14 N208379-003 ZYPITAMAG PITAVASTATIN MAGNESIUM EQ 4MG BASE TABLET / ORAL RLD, RS 2017-07-14
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208379-001 8829186 2031-01-19 Drug substance, Drug product 2017-08-10 N208379-002 8829186 2031-01-19 Drug substance, Drug product 2017-08-10 N208379-003 8829186 2031-01-19 Drug substance, Drug product 2017-08-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N208379-001 ZYPITAMAG EQ 1MG BASE TABLET / ORAL RLD 2017-07-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N208379-002 ZYPITAMAG EQ 2MG BASE TABLET / ORAL RLD 2017-07-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N208379-003 ZYPITAMAG EQ 4MG BASE TABLET / ORAL RLD, RS 2017-07-14 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N208379-001 8829186 2031-01-19 Drug substance, Drug product 2017-08-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N208379-002 8829186 2031-01-19 Drug substance, Drug product 2017-08-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N208379-003 8829186 2031-01-19 Drug substance, Drug product 2017-08-10 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ZYPITAMAG
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PITAVASTATIN 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M5681Q5F9P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2001262 Internal RxNorm lookup 2001264 Internal RxNorm lookup 2001266 Internal RxNorm lookup 2001268 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25208-201-09 ZYPITAMAG 90 in 1 BOTTLE TABLET, FILM COATED 90 14 25208-201-10 ZYPITAMAG 7 in 1 BLISTER PACK TABLET, FILM COATED 7 14 25208-201-10 ZYPITAMAG 1 in 1 CARTON TABLET, FILM COATED 1 14 25208-201-11 ZYPITAMAG 1000 in 1 BOTTLE TABLET, FILM COATED 1000 14 25208-201-12 ZYPITAMAG 10 in 1 BLISTER PACK TABLET, FILM COATED 10 14 25208-201-12 ZYPITAMAG 10 in 1 CARTON TABLET, FILM COATED 10 14 25208-201-13 ZYPITAMAG 30 in 1 BOTTLE TABLET, FILM COATED 30 14 25208-201-14 ZYPITAMAG 100 in 1 BOTTLE TABLET, FILM COATED 100 14 25208-201-15 ZYPITAMAG 500 in 1 BOTTLE TABLET, FILM COATED 500 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25208-201 ZYPITAMAG (PITAVASTATIN MAGNESIUM) TABLET, FILM COATED [MEDICURE INTERNATIONAL INC] 13 Current NDC, Legacy NDC, 9 package rows 20241226_c8c50e03-5cb8-43f4-bdef-8edd12f1945f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25208-201-12 25208020112 10 BLISTER PACK in 1 CARTON (25208-201-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2018-03-09 0000-00-00 No No Current