FDA.reportPublic FDA data

Nilotinib

Product NDC
69097-031
11-digit product format
690970031
Labeler code
69097
Product ID
69097-031_7c40f411-8579-4c45-a820-3b79926a932f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
NDA218922
Marketing category
NDA
Marketing start
2025-06-18
Marketing end
2027-04-30
Substance
NILOTINIB
Active strength
150 mg/1
Pharmacologic classes
Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218922-001NILOTINIB D-TARTRATENILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-19
N218922-002NILOTINIB D-TARTRATENILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-19
N218922-003NILOTINIB D-TARTRATENILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD2025-02-19

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
2026-10-15 13:18:302026-09N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-19c2088c7a36db…
2026-10-15 13:18:302026-09N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-19c2088c7a36db…
2026-10-15 13:18:302026-09N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD2025-02-19c2088c7a36db…
2026-09-14 22:38:342026-08N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-1984e616aacf4f…
2026-09-14 22:38:342026-08N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-1984e616aacf4f…
2026-09-14 22:38:342026-08N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD2025-02-1984e616aacf4f…
2026-08-18 06:07:402026-07N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD, RS2025-02-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD, RS2025-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD, RS2025-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD, RS2025-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD, RS2025-02-19fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218922-001NILOTINIB D-TARTRATEEQ 50MG BASECAPSULE / ORALRLD2025-02-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218922-002NILOTINIB D-TARTRATEEQ 150MG BASECAPSULE / ORALRLD2025-02-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218922-003NILOTINIB D-TARTRATEEQ 200MG BASECAPSULE / ORALRLD, RS2025-02-19a50c72e98297…

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
Nilotinib

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NILOTINIB150 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4599f563-25de-4179-afcc-1a2b06808025Product name120251121
ab6075cd-4ff3-41c7-b0ee-ce177f78fd3cProduct name120250716
28746c76-8e5b-45eb-989c-67bf0a789c1bProduct name220180606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-031-17Nilotinib7 in 1 BLISTER PACKCAPSULE75
69097-031-56Nilotinib4 in 1 CARTONCAPSULE45
69097-031-73Nilotinib2 in 1 CARTONCAPSULE25
69097-031-74Nilotinib4 in 1 CARTONCAPSULE45
69097-031-76Nilotinib14 in 1 BLISTER PACKCAPSULE145
69097-031-91Nilotinib4 in 1 CARTONCAPSULE45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-031-17EA - Each69097-03131b15e8c-7fb5-46f6-b012-b0d6f1b3954712025-12-16
69097-031-56EA - Each69097-0313f36005c-b3bd-42db-8c86-fbfd656e221c12025-07-08
69097-031-74EA - Each69097-03104b409c9-8f4d-4264-95d6-42fdb609b0ea12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715469nilotinib d-tartrate 150 MG Oral CapsulePSNe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715473nilotinib d-tartrate 200 MG Oral CapsulePSNe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715459nilotinib d-tartrate 50 MG Oral CapsulePSNe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715469nilotinib d-tartrate 150 MG Oral CapsuleSCDe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715473nilotinib d-tartrate 200 MG Oral CapsuleSCDe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715459nilotinib d-tartrate 50 MG Oral CapsuleSCDe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715469nilotinib 150 MG (as nilotinib d-tartrate 192.517 MG) Oral CapsuleSYe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715473nilotinib 200 MG (as nilotinib d-tartrate 256.689 MG) Oral CapsuleSYe27c3e09-bc4f-4f01-be05-1c43ac72285d5
2715459nilotinib 50 MG (as nilotinib d-tartrate 64.172 MG) Oral CapsuleSYe27c3e09-bc4f-4f01-be05-1c43ac72285d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-031-17690970031177 in 1 BLISTER PACKHistorical
69097-031-56690970031564 in 1 CARTONHistorical
69097-031-73690970031732 in 1 CARTONHistorical
69097-031-74690970031744 CARTON in 1 CARTON (69097-031-74) / 4 BLISTER PACK in 1 CARTON (69097-031-56) / 7 CAPSULE in 1 BLISTER PACK (69097-031-17) 4 carton2025-06-182027-04-30NoNoHistorical
69097-031-766909700317614 in 1 BLISTER PACKHistorical
69097-031-91690970031914 CARTON in 1 CARTON (69097-031-91) / 2 BLISTER PACK in 1 CARTON (69097-031-73) / 14 CAPSULE in 1 BLISTER PACK (69097-031-76) 4 carton2025-06-182027-04-30NoNoHistorical