Home NDC 52579-1604 Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
Product NDC 52579-1604
11-digit product format 525791604
Labeler code 52579
Product ID 52579-1604_7910c69c-9663-69bd-e053-2991aa0aedb4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tilmanocept
Dosage form KIT
Labeler Navidea Biopharmaceuticals, Inc.
Application NDA202207
Marketing category NDA
Marketing start 2016-10-20
Marketing end 2019-06-01
Active strength 0
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52579-1604-5 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52579-1604-5 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52579-1604-5 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52579-1604-5 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52579-1604-5 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52579-1604-5 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52579-1604-5 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52579-1604-5 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52579-1604-5 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52579-1604-5 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52579-1604-5 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52579-1604-5 557ba5c1ecfa…9c80585c8c6e…
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# 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.