ZYPITAMAG

Product NDC
25208-201
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

Additional Listing Data#

Finished product
Yes
Brand name base
ZYPITAMAG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITAVASTATIN2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM5681Q5F9P
Rxcui2001262, 2001264, 2001266, 2001268

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3b6a39e-87bf-f126-1bde-83d69cbf558bProduct name320250219
de94155c-7345-40be-9a5b-89d04e1ac565Product name120190313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25208-201-09ZYPITAMAG90 in 1 BOTTLETABLET, FILM COATED9014
25208-201-10ZYPITAMAG7 in 1 BLISTER PACKTABLET, FILM COATED714
25208-201-10ZYPITAMAG1 in 1 CARTONTABLET, FILM COATED114
25208-201-11ZYPITAMAG1000 in 1 BOTTLETABLET, FILM COATED100014
25208-201-12ZYPITAMAG10 in 1 BLISTER PACKTABLET, FILM COATED1014
25208-201-12ZYPITAMAG10 in 1 CARTONTABLET, FILM COATED1014
25208-201-13ZYPITAMAG30 in 1 BOTTLETABLET, FILM COATED3014
25208-201-14ZYPITAMAG100 in 1 BOTTLETABLET, FILM COATED10014
25208-201-15ZYPITAMAG500 in 1 BOTTLETABLET, FILM COATED50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25208-201-09EA - Each25208-20162a8f842-1f18-409b-8bea-f0ea7e746ffb12018-04-19
25208-201-15EA - Each25208-201094e8431-66a5-47b8-adc6-b1d57b8be46f12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25208-201ZYPITAMAG (PITAVASTATIN MAGNESIUM) TABLET, FILM COATED [MEDICURE INTERNATIONAL INC]13Current NDC, Legacy NDC, 9 package rows20241226_c8c50e03-5cb8-43f4-bdef-8edd12f1945f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001262pitavastatin magnesium 2 MG Oral TabletPSNc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001266pitavastatin magnesium 4 MG Oral TabletPSNc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001264Zypitamag 2 MG Oral TabletPSNc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001268Zypitamag 4 MG Oral TabletPSNc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001264pitavastatin magnesium 2 MG Oral Tablet [Zypitamag]SBDc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001268pitavastatin magnesium 4 MG Oral Tablet [Zypitamag]SBDc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001262pitavastatin magnesium 2 MG Oral TabletSCDc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001266pitavastatin magnesium 4 MG Oral TabletSCDc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001262pitavastatin 2 MG (as pitavastatin magnesium 2.053 MG) Oral TabletSYc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001266pitavastatin 4 MG (as pitavastatin magnesium 4.106 MG) Oral TabletSYc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001264Zypitamag 2 MG (as pitavastatin magnesium 2.053 MG) Oral TabletSYc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001264Zypitamag 2 MG Oral TabletSYc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001268Zypitamag 4 MG (as pitavastatin magnesium 4.106 MG) Oral TabletSYc8c50e03-5cb8-43f4-bdef-8edd12f1945f14
2001268Zypitamag 4 MG Oral TabletSYc8c50e03-5cb8-43f4-bdef-8edd12f1945f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25208-201-092520802010990 TABLET, FILM COATED in 1 BOTTLE (25208-201-09) 2018-03-090000-00-00NoNoCurrent
25208-201-10252080201101 BLISTER PACK in 1 CARTON (25208-201-10) > 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-03-090000-00-00YesNoCurrent
25208-201-11252080201111000 TABLET, FILM COATED in 1 BOTTLE (25208-201-11) 2018-03-090000-00-00NoNoCurrent
25208-201-122520802011210 BLISTER PACK in 1 CARTON (25208-201-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2018-03-090000-00-00NoNoCurrent
25208-201-132520802011330 TABLET, FILM COATED in 1 BOTTLE (25208-201-13) 2018-03-090000-00-00NoNoCurrent
25208-201-1425208020114100 TABLET, FILM COATED in 1 BOTTLE (25208-201-14) 2018-03-090000-00-00NoNoCurrent
25208-201-1525208020115500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15) 2018-03-090000-00-00NoNoCurrent