FDA.reportPublic FDA data

ZYPITAMAG

Product NDC
70771-1118
11-digit product format
707711118
Labeler code
70771
Product ID
70771-1118_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
4 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-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#

Current patent rows page 1 of 1 · 3 matching rows.

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208379-001ZYPITAMAGEQ 1MG BASETABLET / ORALRLD2017-07-14a50c72e98297…
2026-08-01 22:54:322026-06N208379-002ZYPITAMAGEQ 2MG BASETABLET / ORALRLD2017-07-14a50c72e98297…
2026-08-01 22:54:322026-06N208379-003ZYPITAMAGEQ 4MG BASETABLET / ORALRLD, RS2017-07-14a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208379-00188291862031-01-19Drug substance, Drug product2017-08-10a50c72e98297…
2026-08-01 22:54:322026-06N208379-00288291862031-01-19Drug substance, Drug product2017-08-10a50c72e98297…
2026-08-01 22:54:322026-06N208379-00388291862031-01-19Drug substance, Drug product2017-08-10a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYPITAMAGPITAVASTATIN MAGNESIUMMedicure International Incc8c50e03-5cb8-43f4-bdef-8edd12f1945f2025-12-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 208379
application number: NDA208379
ZYPITAMAGPITAVASTATIN MAGNESIUMZydus Lifesciences Limitede9f0fe3a-0462-4c24-8f22-3c89afe8fcea2024-08-14Exact identifier
application applno (NDA): 208379
application number: NDA208379
ndc (product): 70771-1118

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITAVASTATIN4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M5681Q5F9PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2001262Internal RxNorm lookup
2001264Internal RxNorm lookup
2001266Internal RxNorm lookup
2001268Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9f0fe3a-0462-4c24-8f22-3c89afe8fceaAvailable on FDA.report

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
70771-1118-02021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-12021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-32021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-42021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-52021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-72021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-92021-07-08C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-02020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-12020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-32020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-42020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-52020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-72020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets
70771-1118-92020-01-31C16284748780-19d75b9d0-0af6-f424-e053-dadaa90a57ceZYPITAMAG (pitavastatin) tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1118-0ZYPITAMAG1000 in 1 BOTTLETABLET, FILM COATED10008
70771-1118-1ZYPITAMAG100 in 1 BOTTLETABLET, FILM COATED1008
70771-1118-3ZYPITAMAG30 in 1 BOTTLETABLET, FILM COATED308
70771-1118-4ZYPITAMAG10 in 1 CARTONTABLET, FILM COATED108
70771-1118-4ZYPITAMAG10 in 1 BLISTER PACKTABLET, FILM COATED108
70771-1118-5ZYPITAMAG500 in 1 BOTTLETABLET, FILM COATED5008
70771-1118-7ZYPITAMAG1 in 1 CARTONTABLET, FILM COATED18
70771-1118-7ZYPITAMAG7 in 1 BLISTER PACKTABLET, FILM COATED78
70771-1118-9ZYPITAMAG90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1118ZYPITAMAG (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
70771-1118-0707711118001000 TABLET, FILM COATED in 1 BOTTLE (70771-1118-0) 2018-03-090000-00-00NoNoCurrent
70771-1118-170771111801100 TABLET, FILM COATED in 1 BOTTLE (70771-1118-1) 2018-03-090000-00-00NoNoCurrent
70771-1118-37077111180330 TABLET, FILM COATED in 1 BOTTLE (70771-1118-3) 2018-03-090000-00-00NoNoCurrent
70771-1118-47077111180410 BLISTER PACK in 1 CARTON (70771-1118-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2018-03-090000-00-00NoNoCurrent
70771-1118-570771111805500 TABLET, FILM COATED in 1 BOTTLE (70771-1118-5) 2018-03-090000-00-00NoNoCurrent
70771-1118-7707711118071 BLISTER PACK in 1 CARTON (70771-1118-7) / 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-03-090000-00-00NoNoCurrent
70771-1118-97077111180990 TABLET, FILM COATED in 1 BOTTLE (70771-1118-9) 2018-03-090000-00-00NoNoCurrent