FDA.reportPublic FDA data

ZYPITAMAG

Product NDC
70771-1117
11-digit product format
707711117
Labeler code
70771
Product ID
70771-1117_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pitavastatin Magnesium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208379-001ZYPITAMAGPITAVASTATIN MAGNESIUMEQ 1MG BASETABLET / ORALRLD2017-07-14
N208379-002ZYPITAMAGPITAVASTATIN MAGNESIUMEQ 2MG BASETABLET / ORALRLD2017-07-14
N208379-003ZYPITAMAGPITAVASTATIN MAGNESIUMEQ 4MG BASETABLET / ORALRLD, RS2017-07-14

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208379-00188291862031-01-19Drug substance, Drug product2017-08-10
N208379-00288291862031-01-19Drug substance, Drug product2017-08-10
N208379-00388291862031-01-19Drug substance, Drug product2017-08-10

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYPITAMAGPITAVASTATIN MAGNESIUMZydus Lifesciences Limitede9f0fe3a-0462-4c24-8f22-3c89afe8fcea2024-08-14Exact identifier

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70771-1117-02021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-12021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-32021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-42021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-52021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-72021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-92021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-02020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-12020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-32020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-42020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-52020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-72020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1117-92020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1117-0ZYPITAMAG1000 in 1 BOTTLETABLET, FILM COATED10008
70771-1117-1ZYPITAMAG100 in 1 BOTTLETABLET, FILM COATED1008
70771-1117-3ZYPITAMAG30 in 1 BOTTLETABLET, FILM COATED308
70771-1117-4ZYPITAMAG10 in 1 CARTONTABLET, FILM COATED108
70771-1117-4ZYPITAMAG10 in 1 BLISTER PACKTABLET, FILM COATED108
70771-1117-5ZYPITAMAG500 in 1 BOTTLETABLET, FILM COATED5008
70771-1117-7ZYPITAMAG7 in 1 BLISTER PACKTABLET, FILM COATED78
70771-1117-7ZYPITAMAG1 in 1 CARTONTABLET, FILM COATED18
70771-1117-9ZYPITAMAG90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1117ZYPITAMAG (PITAVASTATIN MAGNESIUM) TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 9 package rows20240817_e9f0fe3a-0462-4c24-8f22-3c89afe8fcea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001262pitavastatin magnesium 2 MG Oral TabletPSNe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001266pitavastatin magnesium 4 MG Oral TabletPSNe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001264Zypitamag 2 MG Oral TabletPSNe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001268Zypitamag 4 MG Oral TabletPSNe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001264pitavastatin magnesium 2 MG Oral Tablet [Zypitamag]SBDe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001268pitavastatin magnesium 4 MG Oral Tablet [Zypitamag]SBDe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001262pitavastatin magnesium 2 MG Oral TabletSCDe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001266pitavastatin magnesium 4 MG Oral TabletSCDe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001262pitavastatin 2 MG (as pitavastatin magnesium 2.053 MG) Oral TabletSYe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001266pitavastatin 4 MG (as pitavastatin magnesium 4.106 MG) Oral TabletSYe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001264Zypitamag 2 MG (as pitavastatin magnesium 2.053 MG) Oral TabletSYe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001264Zypitamag 2 MG Oral TabletSYe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001268Zypitamag 4 MG (as pitavastatin magnesium 4.106 MG) Oral TabletSYe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8
2001268Zypitamag 4 MG Oral TabletSYe9f0fe3a-0462-4c24-8f22-3c89afe8fcea8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1117-0707711117001000 TABLET, FILM COATED in 1 BOTTLE (70771-1117-0) 2018-03-090000-00-00NoNoCurrent
70771-1117-170771111701100 TABLET, FILM COATED in 1 BOTTLE (70771-1117-1) 2018-03-090000-00-00NoNoCurrent
70771-1117-37077111170330 TABLET, FILM COATED in 1 BOTTLE (70771-1117-3) 2018-03-090000-00-00NoNoCurrent
70771-1117-47077111170410 BLISTER PACK in 1 CARTON (70771-1117-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2018-03-090000-00-00NoNoCurrent
70771-1117-570771111705500 TABLET, FILM COATED in 1 BOTTLE (70771-1117-5) 2018-03-090000-00-00NoNoCurrent
70771-1117-7707711117071 BLISTER PACK in 1 CARTON (70771-1117-7) / 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-03-090000-00-00NoNoCurrent
70771-1117-97077111170990 TABLET, FILM COATED in 1 BOTTLE (70771-1117-9) 2018-03-090000-00-00NoNoCurrent