Home NDC 45548-141 TECHNETIUM TC 99M SESTAMIBI
Product NDC 45548-141
11-digit product format 455480141
Labeler code 45548
Product ID 45548-141_b089044e-6c93-4941-94e7-55786e5b57b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Technetium TC 99m Sestamibi
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Jubilant Draximage (USA) Inc.
Application ANDA078806
Marketing category ANDA
Marketing start 2009-07-01
Substance TECHNETIUM TC-99M SESTAMIBI
Active strength 1 mg/mL
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 A078806-001 TECHNETIUM TC 99M SESTAMIBI TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE / INJECTION AP 2009-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078806-001 AP
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 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078806-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TECHNETIUM TC 99M SESTAMIBI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECHNETIUM TC-99M SESTAMIBI 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 971Z4W1S09 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 45548-141-05 TECHNETIUM TC 99M SESTAMIBI 5 in 1 KIT INJECTION, POWDER, FOR SOLUTION 5 14 45548-141-05 TECHNETIUM TC 99M SESTAMIBI 10 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 10 14 45548-141-10 TECHNETIUM TC 99M SESTAMIBI 10 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 10 14 45548-141-10 TECHNETIUM TC 99M SESTAMIBI 10 in 1 KIT INJECTION, POWDER, FOR SOLUTION 10 14 45548-141-30 TECHNETIUM TC 99M SESTAMIBI 30 in 1 KIT INJECTION, POWDER, FOR SOLUTION 30 14 45548-141-30 TECHNETIUM TC 99M SESTAMIBI 10 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 10 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45548-141 TECHNETIUM TC 99M SESTAMIBI INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE (USA) INC.] 14 Current NDC, Legacy NDC, 6 package rows 20211023_07c893fc-cfba-1d98-0232-6448463afb87.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 45548-141-05 45548014105 5 VIAL in 1 KIT (45548-141-05) / 10 mL in 1 VIAL 5 vial 2009-07-01 0000-00-00 No No Current 45548-141-10 45548014110 10 VIAL in 1 KIT (45548-141-10) / 10 mL in 1 VIAL 10 vial 2009-07-01 0000-00-00 No No Current 45548-141-30 45548014130 30 VIAL in 1 KIT (45548-141-30) / 10 mL in 1 VIAL 30 vial 2009-07-01 0000-00-00 No No Current