FDA.reportPublic FDA data

Vascepa

Product NDC
63629-8247
11-digit product format
636298247
Labeler code
63629
Product ID
63629-8247_322776f8-84f9-4198-b95c-353e9df6c70d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
icosapent ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA202057
Marketing category
NDA
Marketing start
2012-10-01
Substance
ICOSAPENT ETHYL
Active strength
1000 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202057-001VASCEPAICOSAPENT ETHYL1GMCAPSULE / ORALABRLD, RS2012-07-26
N202057-002VASCEPAICOSAPENT ETHYL500MGCAPSULE / ORALABRLD2017-02-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N202057-001AB
N202057-002AB

Orange Book patents#

Current patent rows page 1 of 2 · 125 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202057-00197005372027-05-31U-27072020-01-10
N202057-00191988922027-09-25U-27062020-01-10
N202057-001121717382030-02-09U-41052025-01-23
N202057-00184153352030-02-09U-12872013-04-17
N202057-00184263992030-02-09U-1287
N202057-00185189292030-02-09U-1287
N202057-00185246982030-02-09U-12872013-09-11
N202057-00185463722030-02-09U-12872013-10-01
N202057-00186801442030-02-09U-26952020-01-06
N202057-001100105172030-04-29U-26902020-01-06
N202057-001102652872030-04-29U-27002020-01-06
N202057-001107922672030-04-29U-29612020-10-16
N202057-001108427662030-04-29U-29972020-12-11
N202057-001108816322030-04-29U-30522021-02-04
N202057-001111034772030-04-29U-32092021-09-21
N202057-001111545262030-04-29U-32402021-11-08
N202057-001112135042030-04-29U-32922022-02-03
N202057-001117175042030-04-29U-36692023-08-18
N202057-00182985542030-04-29Drug product
N202057-00184450032030-04-29U-1287
N202057-00184450132030-04-29U-1287
N202057-00184549942030-04-29U-26892020-01-06
N202057-00185012252030-04-29U-1287
N202057-00185636082030-04-29U-12872013-10-22
N202057-00186175932030-04-29U-14782014-01-14
N202057-00186175932030-04-29U-26912014-01-14
N202057-00186175942030-04-29U-1287
N202057-00186181662030-04-29U-26892020-01-06
N202057-00186234062030-04-29U-14782014-01-14
N202057-00186234062030-04-29U-26922014-01-14
N202057-00186420772030-04-29U-26932020-01-06
N202057-00186918712030-04-29U-26892020-01-06
N202057-00187031852030-04-29U-26912020-01-06
N202057-00187094752030-04-29U-26892020-01-06
N202057-001108427682030-06-15U-26882020-12-11
N202057-00184100862030-06-15U-26882020-01-06
N202057-00184554722030-06-15U-26902020-01-06
N202057-00186692452030-06-15U-26942020-01-06
N202057-00187100412030-06-15U-26902020-01-06
N202057-001102789352033-06-28U-27012020-01-06
N202057-001102789362033-06-28U-27022020-01-06
N202057-001102789372033-06-28U-27032020-01-06
N202057-001103838402033-06-28U-27042020-01-06
N202057-001105559242033-06-28U-27432020-02-26
N202057-001105559252033-06-28U-27442020-02-26
N202057-001105688612033-06-28U-27562020-03-20
N202057-001105760542033-06-28U-27622020-03-27
N202057-001106680422033-06-28U-28412020-06-26
N202057-001107864782033-06-28U-29592020-10-16
N202057-001107864782033-06-28U-29602020-10-16
N202057-001107922702033-06-28U-29622020-10-16
N202057-001108940282033-06-28U-30532021-02-04
N202057-001110004992033-06-28U-31262021-06-10
N202057-001111167422033-06-28U-32212021-10-08
N202057-001112983332033-06-28U-33582022-05-11
N202057-001113695822033-06-28U-28412022-07-28
N202057-00196038262033-06-28U-26962020-01-06
N202057-00196102722033-06-28U-26972020-01-06
N202057-00196230012033-06-28U-26982020-01-06
N202057-00196939842033-06-28U-26972020-01-06
N202057-00196939852033-06-28U-26962020-01-06
N202057-00196939862033-06-28U-26982020-01-06
N202057-00199189542033-06-28U-26992020-01-06
N202057-00297005372027-05-31U-27072020-01-10
N202057-00291988922027-09-25U-27062020-01-10
N202057-002121717382030-02-09U-41052025-01-23
N202057-00283994462030-02-09U-12872017-06-26
N202057-00284153352030-02-09U-12872017-06-26
N202057-00284263992030-02-09U-12872017-06-26
N202057-00285189292030-02-09U-12872017-06-26
N202057-00285246982030-02-09U-12872017-06-26
N202057-00285463722030-02-09U-12872017-06-26
N202057-00286801442030-02-09U-26952020-01-06
N202057-002100105172030-04-29U-26902020-01-06
N202057-002102652872030-04-29U-27002020-01-06
N202057-002107922672030-04-29U-29612020-10-16
N202057-002108427662030-04-29U-29972020-12-11
N202057-002108816322030-04-29U-30522021-02-04
N202057-002111034772030-04-29U-32092021-09-21
N202057-002111545262030-04-29U-32402021-11-08

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 22:54:322026-06N202057-001VASCEPA1GMCAPSULE / ORALABRLD, RS2012-07-26a50c72e98297…
2026-08-01 22:54:322026-06N202057-002VASCEPA500MGCAPSULE / ORALABRLD2017-02-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N202057-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N202057-002AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N202057-00197005372027-05-31U-27072020-01-10a50c72e98297…
2026-08-01 22:54:322026-06N202057-00191988922027-09-25U-27062020-01-10a50c72e98297…
2026-08-01 22:54:322026-06N202057-001121717382030-02-09U-41052025-01-23a50c72e98297…
2026-08-01 22:54:322026-06N202057-00184153352030-02-09U-12872013-04-17a50c72e98297…
2026-08-01 22:54:322026-06N202057-00184263992030-02-09U-1287a50c72e98297…
2026-08-01 22:54:322026-06N202057-00185189292030-02-09U-1287a50c72e98297…
2026-08-01 22:54:322026-06N202057-00185246982030-02-09U-12872013-09-11a50c72e98297…
2026-08-01 22:54:322026-06N202057-00185463722030-02-09U-12872013-10-01a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186801442030-02-09U-26952020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-001100105172030-04-29U-26902020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-001102652872030-04-29U-27002020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-001107922672030-04-29U-29612020-10-16a50c72e98297…
2026-08-01 22:54:322026-06N202057-001108427662030-04-29U-29972020-12-11a50c72e98297…
2026-08-01 22:54:322026-06N202057-001108816322030-04-29U-30522021-02-04a50c72e98297…
2026-08-01 22:54:322026-06N202057-001111034772030-04-29U-32092021-09-21a50c72e98297…
2026-08-01 22:54:322026-06N202057-001111545262030-04-29U-32402021-11-08a50c72e98297…
2026-08-01 22:54:322026-06N202057-001112135042030-04-29U-32922022-02-03a50c72e98297…
2026-08-01 22:54:322026-06N202057-001117175042030-04-29U-36692023-08-18a50c72e98297…
2026-08-01 22:54:322026-06N202057-00182985542030-04-29Drug producta50c72e98297…
2026-08-01 22:54:322026-06N202057-00184450032030-04-29U-1287a50c72e98297…
2026-08-01 22:54:322026-06N202057-00184450132030-04-29U-1287a50c72e98297…
2026-08-01 22:54:322026-06N202057-00184549942030-04-29U-26892020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00185012252030-04-29U-1287a50c72e98297…
2026-08-01 22:54:322026-06N202057-00185636082030-04-29U-12872013-10-22a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186175932030-04-29U-14782014-01-14a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186175932030-04-29U-26912014-01-14a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186175942030-04-29U-1287a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186181662030-04-29U-26892020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186234062030-04-29U-26922014-01-14a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186234062030-04-29U-14782014-01-14a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186420772030-04-29U-26932020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186918712030-04-29U-26892020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00187031852030-04-29U-26912020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00187094752030-04-29U-26892020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-001108427682030-06-15U-26882020-12-11a50c72e98297…
2026-08-01 22:54:322026-06N202057-00184100862030-06-15U-26882020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00184554722030-06-15U-26902020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00186692452030-06-15U-26942020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-00187100412030-06-15U-26902020-01-06a50c72e98297…
2026-08-01 22:54:322026-06N202057-001102789352033-06-28U-27012020-01-06a50c72e98297…

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
VascepaICOSAPENT ETHYLBryant Ranch Prepackd245ddab-d81b-44bd-90d7-0e4d446d9bf52026-04-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 202057
application number: NDA202057
ndc (product): 63629-8247
VascepaICOSAPENT ETHYLAmarin Pharma Inc.9c1a2828-1583-4414-ab22-a60480e8e5082026-03-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 202057
application number: NDA202057

Additional Listing Data#

Finished product
Yes
Brand name base
Vascepa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICOSAPENT ETHYL1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6GC8A4PAYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1304979Internal RxNorm lookup
1304985Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d245ddab-d81b-44bd-90d7-0e4d446d9bf5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8247-1Vascepa30 in 1 BOTTLECAPSULE307
63629-8247-2Vascepa60 in 1 BOTTLECAPSULE607
63629-8247-3Vascepa120 in 1 BOTTLECAPSULE1207
63629-8247-4Vascepa90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8247VASCEPA (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 4 package rows20240511_d245ddab-d81b-44bd-90d7-0e4d446d9bf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSNd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985Vascepa 1 GM Oral CapsulePSNd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985icosapent ethyl 1000 MG Oral Capsule [Vascepa]SBDd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304979icosapent ethyl 1000 MG Oral CapsuleSCDd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304979icosapent ethyl 1 GM Oral CapsuleSYd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985Vascepa 1 GM Oral CapsuleSYd245ddab-d81b-44bd-90d7-0e4d446d9bf57
1304985Vascepa 1000 MG Oral CapsuleSYd245ddab-d81b-44bd-90d7-0e4d446d9bf57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8247-16362982470130 CAPSULE in 1 BOTTLE (63629-8247-1) 30 capsule2026-04-070000-00-00NoNoCurrent
63629-8247-26362982470260 CAPSULE in 1 BOTTLE (63629-8247-2) 60 capsule2026-04-070000-00-00NoNoCurrent
63629-8247-363629824703120 CAPSULE in 1 BOTTLE (63629-8247-3) 120 capsule2026-04-070000-00-00NoNoCurrent
63629-8247-46362982470490 CAPSULE in 1 BOTTLE (63629-8247-4) 90 capsule2026-04-07NoNoCurrent