FDA.reportPublic FDA data

ICOSAPENT ETHYL

Product NDC
16714-636
11-digit product format
167140636
Labeler code
16714
Product ID
16714-636_ad34781b-7624-4344-a31f-83ef471da07b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA216811
Marketing category
ANDA
Marketing start
2025-07-01
Substance
ICOSAPENT ETHYL
Active strength
1 g/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216811-001ICOSAPENT ETHYLICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-12-07
A216811-002ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2024-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216811-001AB
A216811-002AB

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 22:54:322026-06A216811-001ICOSAPENT ETHYL500MGCAPSULE / ORALAB2023-12-07a50c72e98297…
2026-08-01 22:54:322026-06A216811-002ICOSAPENT ETHYL1GMCAPSULE / ORALAB2024-02-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216811-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216811-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ICOSAPENT ETHYLICOSAPENT ETHYLCamber Pharmaceuticals, Inc.3e3498ab-f35e-4597-8556-89bf9fdd14062026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811
ICOSAPENT ETHYLICOSAPENT ETHYLXLCare Pharmaceuticals, Inc.019cc0ac-0c2f-426d-996a-6d932f9544432026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811
ICOSAPENT ETHYLICOSAPENT ETHYLBryant Ranch Prepackb4a1ca8a-2d22-4c54-9193-eab4e75ba7db2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811
ICOSAPENT ETHYLICOSAPENT ETHYLNorthstar Rx LLCb5b0b1ae-29ab-43a5-9e6d-24374d9613992025-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216811
application number: ANDA216811
ndc (product): 16714-636

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICOSAPENT ETHYL1 g/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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5b0b1ae-29ab-43a5-9e6d-24374d961399Available 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
16714-636-01ICOSAPENT ETHYL120 in 1 BOTTLECAPSULE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-636-01EA - Each16714-636cd190d3c-f242-4d2d-ba87-fc4cfe1c3b9912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSNb5b0b1ae-29ab-43a5-9e6d-24374d9613991
1304979icosapent ethyl 1000 MG Oral CapsuleSCDb5b0b1ae-29ab-43a5-9e6d-24374d9613991
1304979icosapent ethyl 1 GM Oral CapsuleSYb5b0b1ae-29ab-43a5-9e6d-24374d9613991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16714-636-0116714063601120 CAPSULE in 1 BOTTLE (16714-636-01) 120 capsule2025-07-01NoNoCurrent