Home NDC 65174-200 Drax Exametazime
Product NDC 65174-200
11-digit product format 651740200
Labeler code 65174
Product ID 65174-200_9799f139-0c16-4cf0-8a7d-e9668ec3f146
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application NDA208870
Marketing category NDA
Marketing start 2017-08-17
Substance TECHNETIUM TC-99M EXAMETAZIME
Active strength .5 mg/1
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [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 42 .
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 N208870-001 DRAX EXAMETAZIME TECHNETIUM TC-99M EXAMETAZIME KIT N/A POWDER / INTRAVENOUS 2017-08-17
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 · 42 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 2026-08-18 06:07:40 2026-07 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208870-001 DRAX EXAMETAZIME N/A POWDER / INTRAVENOUS 2017-08-17 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Drax Exametazime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECHNETIUM TC-99M EXAMETAZIME .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3B744AG22N Internal UNII 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 65174-200-01 Drax Exametazime 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 4 65174-200-05 Drax Exametazime 5 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65174-200 DRAX EXAMETAZIME (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M EXAMETAZIME FOR LEUKOCYTE LABELING) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] 4 Current NDC, Legacy NDC, 2 package rows 20241208_fa7811f9-2803-4126-8037-8f3e56462f9c.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Drax Exametazime KIT FOR THE PREPARATION OF TECHNETIUM TC 99M EXAMETAZIME FOR LEUKOCYTE LABELING Jubilant DraxImage Inc., dba Jubilant Radiopharma fa7811f9-2803-4126-8037-8f3e56462f9c 2024-12-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 208870 application number: NDA208870 ndc (product): 65174-200
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65174-200-01 65174020001 1 in 1 VIAL Historical 65174-200-05 65174020005 5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01) 5 vial 2017-08-17 0000-00-00 No No Current