Home NDC 65857-450 Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
Product NDC 65857-450
11-digit product format 658570450
Labeler code 65857
Product ID 65857-450_9a68964f-0f50-414d-a7c9-29b6677df463
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tilmanocept
Dosage form KIT
Labeler Cardinal Health 414, LLC
Application NDA202207
Marketing category NDA
Marketing start 2017-09-20
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202207-001 LYMPHOSEEK KIT TECHNETIUM TC-99M TILMANOCEPT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202207-001 9439985 2029-01-30 Drug product 2016-10-14
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 · 41 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 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202207-001 LYMPHOSEEK KIT N/A INJECTABLE / INJECTION RLD, RS 2013-03-13 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 80 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 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202207-001 6409990 2025-05-12 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202207-001 6409990 2025-05-12 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202207-001 6409990 2025-05-12 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202207-001 6409990 2025-05-12 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202207-001 6409990 2025-05-12 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202207-001 6409990 2025-05-12 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202207-001 6409990 2025-05-12 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202207-001 6409990 2025-05-12 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202207-001 6409990 2025-05-12 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202207-001 6409990 2025-05-12 Drug substance 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202207-001 6409990 2025-05-12 Drug substance 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202207-001 6409990 2025-05-12 Drug substance 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202207-001 6409990 2025-05-12 Drug substance 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202207-001 9439985 2029-01-30 Drug product 2016-10-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202207-001 6409990 2025-05-12 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202207-001 9439985 2033-09-27 Drug substance, Drug product 2016-10-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202207-001 6409990 2025-05-12 Drug substance 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202207-001 9439985 2033-09-27 Drug substance, Drug product 2016-10-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202207-001 6409990 2025-05-12 Drug substance 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202207-001 9439985 2033-09-27 Drug substance, Drug product 2016-10-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202207-001 6409990 2020-05-12 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202207-001 9439985 2033-09-27 Drug substance, Drug product 2016-10-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202207-001 6409990 2025-05-12 Drug substance bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202207-001 9439985 2033-09-27 Drug substance, Drug product 2016-10-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202207-001 6409990 2025-05-12 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202207-001 9439985 2033-09-27 Drug substance, Drug product 2016-10-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202207-001 6409990 2025-05-12 Drug substance 87673890dc5c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
Listing expiration 2026-12-31 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 65857-450-05 Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) 1 in 1 KIT KIT 1 7 65857-450-05 Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) 1 in 1 CARTON KIT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65857-450 KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) (TILMANOCEPT) KIT [CARDINAL HEALTH 414, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20230928_72f31b09-4d7b-475c-b37a-9daf2ad80240.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65857-450-05 65857045005 1 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45) 1 kit 2017-09-20 0000-00-00 No No Current