FDA.reportPublic FDA data

KOSELUGO

Product NDC
0310-0640
11-digit product format
003100640
Labeler code
0310
Product ID
0310-0640_b3809b9c-c5d0-44c6-9c21-abcc230f64ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SELUMETINIB
Dosage form
GRANULE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA219943
Marketing category
NDA
Marketing start
2025-09-10
Substance
SELUMETINIB
Active strength
7.5 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219943-001KOSELUGOSELUMETINIB SULFATEEQ 5MG BASEGRANULE / ORALRLD, RS2025-09-10
N219943-002KOSELUGOSELUMETINIB SULFATEEQ 7.5MG BASEGRANULE / ORALRLD2025-09-10

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219943-00181786932026-03-13Drug substance, Drug product2025-09-30
N219943-00191567952026-12-12Drug substance, Drug product2025-09-30
N219943-00195620172026-12-12U-4357Drug substance2025-09-30
N219943-00174256372028-03-13Drug substance2025-09-30
N219943-00281786932026-03-13Drug substance, Drug product2025-09-30
N219943-00291567952026-12-12Drug substance, Drug product2025-09-30
N219943-00295620172026-12-12U-4357Drug substance2025-09-30
N219943-00274256372028-03-13Drug substance2025-09-30

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219943-001ODE*2027-04-10
N219943-001NP2028-09-10
N219943-001NPP2028-11-19
N219943-001ODE*2032-11-19
N219943-002ODE*2027-04-10
N219943-002NP2028-09-10
N219943-002NPP2028-11-19
N219943-002ODE*2032-11-19

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
2026-02-19 14:30 UTC2026-02N219943-001KOSELUGOEQ 5MG BASEGRANULE / ORALRLD2025-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-002KOSELUGOEQ 7.5MG BASEGRANULE / ORALRLD, RS2025-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-001KOSELUGOEQ 5MG BASEGRANULE / ORALRLD2025-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-002KOSELUGOEQ 7.5MG BASEGRANULE / ORALRLD, RS2025-09-1031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-001KOSELUGOEQ 5MG BASEGRANULE / ORALRLD, RS2025-09-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-002KOSELUGOEQ 7.5MG BASEGRANULE / ORALRLD2025-09-10a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219943-00181786932026-03-13Drug substance, Drug product2025-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-00191567952026-12-12Drug substance, Drug product2025-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-00195620172026-12-12U-4357Drug substance2025-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-00174256372028-03-13Drug substance2025-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-00281786932026-03-13Drug substance, Drug product2025-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-00291567952026-12-12Drug substance, Drug product2025-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-00295620172026-12-12U-4357Drug substance2025-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-00274256372028-03-13Drug substance2025-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00174256372026-03-13Drug substance2025-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00181786932026-03-13Drug substance, Drug product2025-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00191567952026-12-12Drug substance, Drug product2025-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00195620172026-12-12U-4274Drug substance2025-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00274256372026-03-13Drug substance2025-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00281786932026-03-13Drug substance, Drug product2025-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00291567952026-12-12Drug substance, Drug product2025-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-00295620172026-12-12U-4274Drug substance2025-09-3031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00181786932026-03-13Drug substance, Drug product2025-09-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00191567952026-12-12Drug substance, Drug product2025-09-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00195620172026-12-12U-4357Drug substance2025-09-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00174256372028-03-13Drug substance2025-09-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00281786932026-03-13Drug substance, Drug product2025-09-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00291567952026-12-12Drug substance, Drug product2025-09-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00295620172026-12-12U-4357Drug substance2025-09-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-00274256372028-03-13Drug substance2025-09-30a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N219943-001ODE*2027-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-001NP2028-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-001NPP2028-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-002ODE*2027-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-002NP2028-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219943-002NPP2028-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-001ODE*2027-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-001NP2028-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-002ODE*2027-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219943-002NP2028-09-1031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-001ODE*2027-04-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-001NP2028-09-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-001NPP2028-11-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-001ODE*2032-11-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-002ODE*2027-04-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-002NP2028-09-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-002NPP2028-11-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219943-002ODE*2032-11-19a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELUMETINIB7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6UH91I579UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2289418Internal RxNorm lookup
2289424Internal RxNorm lookup
2289426Internal RxNorm lookup
2289428Internal RxNorm lookup
2723653Internal RxNorm lookup
2723657Internal RxNorm lookup
2723659Internal RxNorm lookup
2723661Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d042c61-f28f-4ab5-ab10-d7558c0d49ffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
8ba1a9aa-3486-4082-812d-f96073e22305Product name120200504
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-0640-60KOSELUGO60 in 1 BOTTLEGRANULE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0640-60EA - Each0310-064060192afe-e7a5-43db-ae45-df8603b4280812025-11-13

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
KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LP7d042c61-f28f-4ab5-ab10-d7558c0d49ff2026-05-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 219943
application number: NDA219943
ndc (product): 0310-0640

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2289424Koselugo 10 MG Oral CapsulePSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289428Koselugo 25 MG Oral CapsulePSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723657Koselugo 5 MG Oral GranulesPSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723661Koselugo 7.5 MG Oral GranulesPSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289418selumetinib 10 MG Oral CapsulePSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289426selumetinib 25 MG Oral CapsulePSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723653selumetinib 5 MG Oral GranulesPSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723659selumetinib 7.5 MG Oral GranulesPSN7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289424selumetinib 10 MG Oral Capsule [Koselugo]SBD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289428selumetinib 25 MG Oral Capsule [Koselugo]SBD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723657selumetinib 5 MG Oral Granules [Koselugo]SBD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723661selumetinib 7.5 MG Oral Granules [Koselugo]SBD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289418selumetinib 10 MG Oral CapsuleSCD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289426selumetinib 25 MG Oral CapsuleSCD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723653selumetinib 5 MG Oral GranulesSCD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723659selumetinib 7.5 MG Oral GranulesSCD7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289424Koselugo 10 MG Oral CapsuleSY7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289428Koselugo 25 MG Oral CapsuleSY7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723657Koselugo 5 MG Oral GranulesSY7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2723661Koselugo 7.5 MG Oral GranulesSY7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289418selumetinib (as selumetinib sulfate) 10 MG Oral CapsuleSY7d042c61-f28f-4ab5-ab10-d7558c0d49ff17
2289426selumetinib (as selumetinib sulfate) 25 MG Oral CapsuleSY7d042c61-f28f-4ab5-ab10-d7558c0d49ff17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0310-0640-600031006406060 GRANULE in 1 BOTTLE (0310-0640-60) 60 granule2025-09-10NoNoCurrent