Home NDC 65174-261 TECHNETIUM Tc 99m MERTIATIDE
Product NDC 65174-261
11-digit product format 651740261
Labeler code 65174
Product ID 65174-261_c7627788-6211-4255-82a9-ec12343149f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Technetium Tc 99m Mertiatide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application NDA216820
Marketing category NDA
Marketing start 2023-03-31
Substance BETIATIDE
Active strength 1 mg/1
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 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT TECHNETIUM TC-99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30
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.
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 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216820-001 TECHNETIUM TC 99M MERTIATIDE KIT N/A POWDER / INTRAVENOUS RLD, RS 2023-01-30 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base TECHNETIUM Tc 99m MERTIATIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETIATIDE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9NV2SR34P8 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 65174-261-01 TECHNETIUM Tc 99m MERTIATIDE 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 4 65174-261-05 TECHNETIUM Tc 99m MERTIATIDE 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 65174-261 TECHNETIUM TC 99M MERTIATIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] 4 Current NDC, 2 package rows 20230331_d497f2a2-8e8d-4372-ba09-f8e6b22d2cf8.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 Sample Exclude flag Status 65174-261-01 65174026101 1 in 1 VIAL Historical 65174-261-05 65174026105 5 VIAL in 1 CARTON (65174-261-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-261-01) 5 vial 2023-03-31 No No Current