FDA.reportPublic FDA data

nilotinib

Product NDC
13668-710
11-digit product format
136680710
Labeler code
13668
Product ID
13668-710_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
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
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
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
2026-08-01 22:54:322026-06A218532-001NILOTINIB HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2025-12-15a50c72e98297…
2026-08-01 22:54:322026-06A218532-002NILOTINIB HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2025-12-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218532-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218532-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 13668-710

Additional Listing Data#

Finished product
Yes
Brand name base
nilotinib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NILOTINIB HYDROCHLORIDE MONOHYDRATE150 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
746606Internal RxNorm lookup
997653Internal RxNorm 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
13668-710-57nilotinib4 in 1 CARTONCAPSULE45
13668-710-57nilotinib28 in 1 BLISTER PACKCAPSULE285
13668-710-91nilotinib28 in 1 BLISTER PACKCAPSULE285
13668-710-91nilotinib1 in 1 CARTONCAPSULE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-710-57EA - Each13668-710fd3feb4b-5d98-4bb9-b9e9-b54ea8a199c912026-01-08
13668-710-91EA - Each13668-710c32c0b92-a23c-4113-a17e-321d85794ea412026-01-08

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
13668-710-57136680710574 BLISTER PACK in 1 CARTON (13668-710-57) / 28 CAPSULE in 1 BLISTER PACK4 blister pack2025-12-16NoNoCurrent
13668-710-91136680710911 BLISTER PACK in 1 CARTON (13668-710-91) / 28 CAPSULE in 1 BLISTER PACK1 blister pack2025-12-16NoNoCurrent