FDA.reportPublic FDA data

AVMAPKI FAKZYNJA CO-PACK

Product NDC
71779-623
Requested package NDC
71779-623-01
11-digit product format
717790623
Labeler code
71779
Product ID
71779-623_e6def323-179c-432e-957d-fc4ea03e1b78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
avutometinib potassium and defactinib hydrochloride
Dosage form
KIT
Labeler
Verastem Inc.
Application
NDA219616
Marketing category
NDA
Marketing start
2025-05-08
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 43.

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
N219616-001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDEEQ 0.8MG BASE;EQ 200MG BASECAPSULE, TABLET / ORALRLD, RS2025-05-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219616-00178977922027-02-09Drug substance, Drug product2025-06-03
N219616-00182474112028-04-17Drug substance, Drug product2025-06-03
N219616-00179281092029-08-21Drug substance, Drug product2025-06-03
N219616-001114000902038-10-29U-41962025-06-03
N219616-001115175732040-09-11U-41962025-06-03
N219616-001115175732040-09-11U-42052025-06-03
N219616-001118732962042-12-29U-4196Drug product2025-06-03
N219616-001125094502042-12-29Drug product2026-01-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219616-001NCE2030-05-08
N219616-001ODE-5252032-05-08

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
2026-09-14 22:38:342026-08N219616-001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)EQ 0.8MG BASE;EQ 200MG BASECAPSULE, TABLET / ORALRLD, RS2025-05-0884e616aacf4f…
2026-08-18 06:07:402026-07N219616-001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)EQ 0.8MG BASE;EQ 200MG BASECAPSULE, TABLET / ORALRLD, RS2025-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219616-001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)EQ 0.8MG BASE;EQ 200MG BASECAPSULE, TABLET / ORALRLD, RS2025-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)EQ 0.8MG BASE;EQ 200MG BASECAPSULE, TABLET / ORALRLD, RS2025-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N219616-001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)EQ 0.8MG BASE;EQ 200MG BASECAPSULE, TABLET / ORALRLD, RS2025-05-086a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219616-001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)EQ 0.8MG BASE;EQ 200MG BASECAPSULE, TABLET / ORALRLD, RS2025-05-08a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219616-00178977922027-02-09Drug substance, Drug product2025-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N219616-00182474112028-04-17Drug substance, Drug product2025-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N219616-00179281092029-08-21Drug substance, Drug product2025-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N219616-001114000902038-10-29U-41962025-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N219616-001115175732040-09-11U-41962025-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N219616-001115175732040-09-11U-42052025-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N219616-001118732962042-12-29U-4196Drug product2025-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N219616-001125094502042-12-29Drug product2026-01-2884e616aacf4f…
2026-08-18 06:07:402026-07N219616-00178977922027-02-09Drug substance, Drug product2025-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-00182474112028-04-17Drug substance, Drug product2025-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-00179281092029-08-21Drug substance, Drug product2025-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-001114000902038-10-29U-41962025-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-001115175732040-09-11U-41962025-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-001115175732040-09-11U-42052025-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-001118732962042-12-29U-4196Drug product2025-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-001125094502042-12-29Drug product2026-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219616-00178977922027-02-09Drug substance, Drug product2025-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219616-00182474112028-04-17Drug substance, Drug product2025-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219616-00179281092029-08-21Drug substance, Drug product2025-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219616-001114000902038-10-29U-41962025-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219616-001115175732040-09-11U-41962025-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219616-001115175732040-09-11U-42052025-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219616-001118732962042-12-29U-4196Drug product2025-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219616-001125094502042-12-29Drug product2026-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-00178977922027-02-09Drug substance, Drug product2025-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-00182474112028-04-17Drug substance, Drug product2025-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-00179281092029-08-21Drug substance, Drug product2025-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-001114000902038-10-29U-41962025-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-001115175732040-09-11U-41962025-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-001115175732040-09-11U-42052025-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-001118732962042-12-29U-4196Drug product2025-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219616-00178977922027-02-09Drug substance, Drug product2025-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219616-00182474112028-04-17Drug substance, Drug product2025-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219616-00179281092029-08-21Drug substance, Drug product2025-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219616-001114000902038-10-29U-41962025-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219616-001115175732040-09-11U-41962025-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219616-001115175732040-09-11U-42052025-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219616-001118732962042-12-29U-4196Drug product2025-06-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219616-00178977922027-02-09Drug substance, Drug product2025-06-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219616-00182474112028-04-17Drug substance, Drug product2025-06-03a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219616-001NCE2030-05-0884e616aacf4f…
2026-09-14 22:38:342026-08N219616-001ODE-5252032-05-0884e616aacf4f…
2026-08-18 06:07:402026-07N219616-001NCE2030-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219616-001ODE-5252032-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219616-001NCE2030-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219616-001NCE2030-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N219616-001NCE2030-05-086a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219616-001NCE2030-05-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219616-001ODE-5252032-05-08a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
AVMAPKI FAKZYNJA CO-PACK
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2714507Internal RxNorm lookup
2714513Internal RxNorm lookup
2714520Internal RxNorm lookup
2714526Internal RxNorm lookup
2714921Internal RxNorm lookup
2714922Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65889527-1406-45df-8a85-e2690dcf427dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a996781d-85e8-4f5b-bb0b-fde31fc06dfeProduct name120260223
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
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
71779-623-01AVMAPKI FAKZYNJA CO-PACK1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71779-623-01EA - Each71779-6233713845a-6d31-4df2-98b6-d4a89a9a784e12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71779-623AVMAPKI FAKZYNJA CO-PACK (AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE) KIT [VERASTEM INC.]2Current NDC, 1 package rows20250523_65889527-1406-45df-8a85-e2690dcf427d.zip

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
AVMAPKI FAKZYNJA CO-PACKAVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDEVerastem Inc.65889527-1406-45df-8a85-e2690dcf427d2025-05-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 219616
application number: NDA219616
ndc (package): 71779-623-01
ndc (product): 71779-623
ndc11 (package): 71779062301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2714922{24 (avutometinib 0.8 MG Oral Capsule [Avmapki]) / 42 (defactinib 200 MG Oral Tablet [Fakzynja]) } Pack [Avmapki Fakzynja Co-Pack]BPCK65889527-1406-45df-8a85-e2690dcf427d2
2714921{24 (avutometinib 0.8 MG Oral Capsule) / 42 (defactinib 200 MG Oral Tablet) } PackGPCK65889527-1406-45df-8a85-e2690dcf427d2
2714526AVMAPKI 0.8 MG Oral CapsulePSN65889527-1406-45df-8a85-e2690dcf427d2
2714922AVMAPKI FAKZYNJA Co-PackPSN65889527-1406-45df-8a85-e2690dcf427d2
2714520avutometinib 0.8 MG Oral CapsulePSN65889527-1406-45df-8a85-e2690dcf427d2
2714921avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-PackPSN65889527-1406-45df-8a85-e2690dcf427d2
2714507defactinib 200 MG Oral TabletPSN65889527-1406-45df-8a85-e2690dcf427d2
2714513FAKZYNJA 200 MG Oral TabletPSN65889527-1406-45df-8a85-e2690dcf427d2
2714526avutometinib 0.8 MG Oral Capsule [Avmapki]SBD65889527-1406-45df-8a85-e2690dcf427d2
2714513defactinib 200 MG Oral Tablet [Fakzynja]SBD65889527-1406-45df-8a85-e2690dcf427d2
2714520avutometinib 0.8 MG Oral CapsuleSCD65889527-1406-45df-8a85-e2690dcf427d2
2714507defactinib 200 MG Oral TabletSCD65889527-1406-45df-8a85-e2690dcf427d2
2714526Avmapki 0.8 MG (equivalent to avutometinib potassium 0.864 MG) Oral CapsuleSY65889527-1406-45df-8a85-e2690dcf427d2
2714922Avmapki Fakzynja Co-PackSY65889527-1406-45df-8a85-e2690dcf427d2
2714520avutometinib 0.8 MG (equivalent to avutometinib potassium 0.864 MG) Oral CapsuleSY65889527-1406-45df-8a85-e2690dcf427d2
2714921avutometinib 0.8 MG Oral Capsule / defactinib 200 MG Oral Tablet Co-PackSY65889527-1406-45df-8a85-e2690dcf427d2
2714507defactinib 200 MG (equivalent to defactinib hydrochloride 214.36 MG) Oral TabletSY65889527-1406-45df-8a85-e2690dcf427d2
2714513Fakzynja 200 MG (equivalent to defactinib hydrochloride 214.36 MG) Oral TabletSY65889527-1406-45df-8a85-e2690dcf427d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71779-623-01717790623011 KIT in 1 CARTON (71779-623-01) * 24 CAPSULE in 1 BOTTLE (71779-660-02) * 42 TABLET in 1 BOTTLE (71779-630-01) 1 kit2025-05-08NoNoCurrent