FDA.reportPublic FDA data

nilotinib

Product NDC
13668-711
11-digit product format
136680711
Labeler code
13668
Product ID
13668-711_8e83f910-85f0-4646-b330-179f02acddf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nilotinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA218532
Marketing category
ANDA
Marketing start
2025-12-16
Substance
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Active strength
200 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
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A218532-001NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2025-12-15
A218532-002NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2025-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218532-001AB
A218532-002AB

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
2026-08-18 06:07:402026-07A218532-001NILOTINIB HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2025-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A218532-002NILOTINIB HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2025-12-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218532-001NILOTINIB HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2025-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218532-002NILOTINIB HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2025-12-15011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218532-001NILOTINIB HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2025-12-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218532-002NILOTINIB HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2025-12-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218532-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218532-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218532-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218532-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218532-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218532-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NILOTINIB HYDROCHLORIDE MONOHYDRATE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5JHU0N1R6KInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b34e7fd4-53c5-46d8-bf8a-1fcbe7a16504Available on FDA.report

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
13668-711-57nilotinib4 in 1 CARTONCAPSULE45
13668-711-57nilotinib28 in 1 BLISTER PACKCAPSULE285
13668-711-91nilotinib1 in 1 CARTONCAPSULE15
13668-711-91nilotinib28 in 1 BLISTER PACKCAPSULE285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-711-57EA - Each13668-711b279b8c1-159f-4777-9808-4ae5aee9f67a12026-01-08
13668-711-91EA - Each13668-711dfb70d29-f942-4970-879f-bad23e5fd2ca12026-01-08

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
nilotinibNILOTINIBTorrent Pharmaceuticals Limitedb34e7fd4-53c5-46d8-bf8a-1fcbe7a165042025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218532
application number: ANDA218532
ndc (product): 13668-711

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997653nilotinib 150 MG Oral CapsulePSNb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
746606nilotinib 200 MG Oral CapsulePSNb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
997653nilotinib 150 MG Oral CapsuleSCDb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
746606nilotinib 200 MG Oral CapsuleSCDb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
997653nilotinib (as nilotinib HCl) 150 MG Oral CapsuleSYb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045
746606nilotinib (as nilotinib HCl) 200 MG Oral CapsuleSYb34e7fd4-53c5-46d8-bf8a-1fcbe7a165045

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-711-57136680711574 BLISTER PACK in 1 CARTON (13668-711-57) / 28 CAPSULE in 1 BLISTER PACK4 blister pack2025-12-16NoNoCurrent
13668-711-91136680711911 BLISTER PACK in 1 CARTON (13668-711-91) / 28 CAPSULE in 1 BLISTER PACK1 blister pack2025-12-16NoNoCurrent