Home NDC 0069-0251 Xalkori
Product NDC 0069-0251
11-digit product format 000690251
Labeler code 0069
Product ID 0069-0251_f5e01d3a-43fc-4fa6-b5dd-a07330b49328
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CRIZOTINIB
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA217581
Marketing category NDA
Marketing start 2023-11-20
Substance CRIZOTINIB
Active strength 20 mg/1
Pharmacologic classes Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Receptor Tyrosine Kinase 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217581-001 XALKORI CRIZOTINIB 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 N217581-002 XALKORI CRIZOTINIB 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 N217581-003 XALKORI CRIZOTINIB 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217581-001 7825137 2027-05-12 U-3057 2023-10-06 N217581-001 7825137 2027-05-12 U-3058 2023-10-06 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 N217581-001 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 N217581-001 8217057 2029-11-06 Drug substance 2023-10-06 N217581-002 7825137 2027-05-12 U-3057 2023-10-06 N217581-002 7825137 2027-05-12 U-3058 2023-10-06 N217581-002 7825137 2027-05-12 U-3403 2023-10-06 N217581-002 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 N217581-002 8217057 2029-11-06 Drug substance 2023-10-06 N217581-003 7825137 2027-05-12 U-3057 2023-10-06 N217581-003 7825137 2027-05-12 U-3058 2023-10-06 N217581-003 7825137 2027-05-12 U-3403 2023-10-06 N217581-003 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 N217581-003 8217057 2029-11-06 Drug substance 2023-10-06
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.
Product history page 1 of 2 · 60 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 11 · 408 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217581-001 7825137 2027-05-12 U-3057 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 7825137 2027-05-12 U-3058 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 8217057 2029-11-06 Drug substance 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7825137 2027-05-12 U-3057 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7825137 2027-05-12 U-3058 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7825137 2027-05-12 U-3403 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 8217057 2029-11-06 Drug substance 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7825137 2027-05-12 U-3403 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7825137 2027-05-12 U-3057 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7825137 2027-05-12 U-3058 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 8217057 2029-11-06 Drug substance 2023-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7230098 2025-08-26 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7825137 2027-05-12 U-3057 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7825137 2027-05-12 U-3058 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 8217057 2029-11-06 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7230098 2025-08-26 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7825137 2027-05-12 U-3057 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7825137 2027-05-12 U-3058 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7825137 2027-05-12 U-3403 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 8217057 2029-11-06 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7230098 2025-08-26 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7825137 2027-05-12 U-3403 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7825137 2027-05-12 U-3057 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7825137 2027-05-12 U-3058 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 8217057 2029-11-06 Drug substance 2023-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217581-001 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-001 7230098 2025-08-26 Drug substance 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-001 7825137 2027-05-12 U-3057 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Xalkori
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CRIZOTINIB 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 53AH36668S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1148498 Internal RxNorm lookup 1148502 Internal RxNorm lookup 1148504 Internal RxNorm lookup 1148506 Internal RxNorm lookup 2670166 Internal RxNorm lookup 2670170 Internal RxNorm lookup 2670172 Internal RxNorm lookup 2670174 Internal RxNorm lookup 2670176 Internal RxNorm lookup 2670178 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0251-60 Xalkori 60 in 1 BOTTLE CAPSULE, COATED PELLETS 60 46
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0251 XALKORI (CRIZOTINIB) CAPSULE XALKORI (CRIZOTINIB) CAPSULE, COATED PELLETS [PFIZER LABORATORIES DIV PFIZER INC] 45 Current NDC, 1 package rows 20250109_2a51b0de-47d6-455e-a94c-d2c737b04ff7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0069-0251-60 00069025160 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60) 2023-11-20 No No Current