FDA.reportPublic FDA data

Icosapent Ethyl

Product NDC
60429-005
11-digit product format
604290005
Labeler code
60429
Product ID
60429-005_36370268-ebc0-8ab1-e063-6394a90adc9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icosapent Ethyl
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA209437
Marketing category
ANDA
Marketing start
2021-06-30
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209437-001ICOSAPENT ETHYLICOSAPENT ETHYL1GMCAPSULE / ORALAB2021-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209437-001AB

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 22:54:322026-06A209437-001ICOSAPENT ETHYL1GMCAPSULE / ORALAB2021-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209437-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icosapent EthylICOSAPENT ETHYLApotex Corp886aa8d8-b293-258f-b16d-be40418787a82026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209437
application number: ANDA209437
Icosapent EthylICOSAPENT ETHYLAmerican Health Packagingfd28217d-5817-43b0-8185-7c7ec6da83f32026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209437
application number: ANDA209437
Icosapent EthylICOSAPENT ETHYLGolden State Medical Supply, Inc.3637187f-70bc-eb31-e063-6294a90ad3cb2025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209437
application number: ANDA209437
ndc (product): 60429-005

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
3637187f-70bc-eb31-e063-6294a90ad3cbAvailable 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
60429-005-12Icosapent Ethyl120 in 1 BOTTLECAPSULE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-005-12EA - Each60429-0058e8c686a-e9d8-4445-9db3-24b610b1382012025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304979icosapent ethyl 1 GM Oral CapsulePSN3637187f-70bc-eb31-e063-6294a90ad3cb1
1304979icosapent ethyl 1000 MG Oral CapsuleSCD3637187f-70bc-eb31-e063-6294a90ad3cb1
1304979icosapent ethyl 1 GM Oral CapsuleSY3637187f-70bc-eb31-e063-6294a90ad3cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60429-005-1260429000512120 CAPSULE in 1 BOTTLE (60429-005-12) 120 capsule2025-03-31NoNoCurrent