FDA.reportPublic FDA data

ICOTYDE

Product NDC
57894-201
11-digit product format
578940201
Labeler code
57894
Product ID
57894-201_4d42efb1-d399-2a77-e063-6294a90af3cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
icotrokinra
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Biotech, Inc.
Application
NDA220149
Marketing category
NDA
Marketing start
2026-03-17
Substance
ICOTROKINRA
Active strength
200 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220149-001ICOTYDEICOTROKINRA HYDROCHLORIDEEQ 200MG BASETABLET / ORALRLD, RS2026-03-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220149-001125528362039-07-12Drug substance, Drug product2026-04-02
N220149-001118458082041-01-14U-4447Drug substance2026-04-02
N220149-001119393612041-11-19U-4447Drug product2026-04-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220149-001NCE2031-03-17

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220149-001ICOTYDEEQ 200MG BASETABLET / ORALRLD, RS2026-03-17a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220149-001125528362039-07-12Drug substance, Drug product2026-04-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220149-001118458082041-01-14U-4447Drug substance2026-04-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220149-001119393612041-11-19U-4447Drug product2026-04-02a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220149-001NCE2031-03-17a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICOTROKINRA200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MUW8FP7HNZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2739036Internal RxNorm lookup
2739042Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aee3c963-edc0-4252-8769-cdf6c7cdc21aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-201-01ICOTYDE7 in 1 BLISTER PACKTABLET, FILM COATED72
57894-201-07ICOTYDE1 in 1 CARTONTABLET, FILM COATED12
57894-201-30ICOTYDE30 in 1 BOTTLETABLET, FILM COATED302
57894-201-30ICOTYDE1 in 1 CARTONTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-201-01EA - Each57894-2017a3d39bf-1380-446a-bedf-79dbdc929cc812026-05-22
57894-201-07EA - Each57894-201e7ede252-4df2-42cc-ac94-ecc002df5a8512026-05-22
57894-201-30EA - Each57894-201b7c2deeb-88e1-4ad9-af25-6ea59151088712026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ICOTYDEICOTROKINRAJanssen Biotech, Inc.aee3c963-edc0-4252-8769-cdf6c7cdc21a2026-03-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 220149
application number: NDA220149
ndc (product): 57894-201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739036icotrokinra 200 MG Oral TabletPSNaee3c963-edc0-4252-8769-cdf6c7cdc21a2
2739042ICOTYDE 200 MG Oral TabletPSNaee3c963-edc0-4252-8769-cdf6c7cdc21a2
2739042icotrokinra 200 MG Oral Tablet [Icotyde]SBDaee3c963-edc0-4252-8769-cdf6c7cdc21a2
2739036icotrokinra 200 MG Oral TabletSCDaee3c963-edc0-4252-8769-cdf6c7cdc21a2
2739036icotrokinra (as icotrokinra hydrochloride) 200 MG Oral TabletSYaee3c963-edc0-4252-8769-cdf6c7cdc21a2
2739042Icotyde (as icotrokinra hydrochloride) 200 MG Oral TabletSYaee3c963-edc0-4252-8769-cdf6c7cdc21a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57894-201-01578940201017 in 1 BLISTER PACKHistorical
57894-201-07578940201071 BLISTER PACK in 1 CARTON (57894-201-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK (57894-201-01) 1 blister pack2026-03-17NoNoCurrent
57894-201-30578940201301 BOTTLE in 1 CARTON (57894-201-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-03-17NoNoCurrent