Home NDC 0069-0227 Lorbrena
Product NDC 0069-0227
11-digit product format 000690227
Labeler code 0069
Product ID 0069-0227_fa9433bd-5ed2-47c3-84cb-f751c1345f81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lorlatinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA210868
Marketing category NDA
Marketing start 2018-11-19
Substance LORLATINIB
Active strength 25 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Cation Transporter 1 Inhibitors [MoA], P-Glycoprotein Inducers [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210868-001 LORBRENA LORLATINIB 25MG TABLET / ORAL RLD 2018-11-02 N210868-002 LORBRENA LORLATINIB 100MG TABLET / ORAL RLD, RS 2018-11-02
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210868-001 ODE-349 2028-03-03 N210868-002 ODE-349 2028-03-03
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 3 · 82 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 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 9 · 352 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 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 11 · 404 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lorbrena
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORLATINIB 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OSP71S83EU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2103169 Internal RxNorm lookup 2103175 Internal RxNorm lookup 2103177 Internal RxNorm lookup 2103179 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0227-01 Lorbrena 30 in 1 BOTTLE TABLET, FILM COATED 30 12 0069-0227-03 Lorbrena 120 in 1 BOTTLE TABLET, FILM COATED 120 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0227 LORBRENA (LORLATINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 9 Current NDC, Legacy NDC, 2 package rows 20250503_2b34d62d-e02a-4af3-bc0d-1571dd4ee76d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0069-0227-01 00069022701 30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01) 2018-11-19 0000-00-00 No No Current 0069-0227-03 00069022703 120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03) 2025-01-03 2027-03-31 No No Historical