Home NDC 45567-0455 Kit for the Preparation of Technetium Tc 99m Mebrofenin
Product NDC 45567-0455
11-digit product format 455670455
Labeler code 45567
Product ID 45567-0455_20bf6038-c480-0b7f-e063-6394a90a8d65
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Kit for the Preparation of Technetium Tc 99m Mebrofenin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078242
Marketing category ANDA
Marketing start 2008-01-29
Substance MEBROFENIN
Active strength 45 mg/10mL
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 A078242-001 TECHNETIUM TC-99M MEBROFENIN TECHNETIUM TC-99M MEBROFENIN KIT N/A INJECTABLE / INJECTION AP 2008-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078242-001 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 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078242-001 TECHNETIUM TC-99M MEBROFENIN N/A INJECTABLE / INJECTION AP 2008-01-29 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 Kit for the Preparation of Technetium Tc 99m Mebrofenin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEBROFENIN 45 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7PV0B6ED98 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45567-0455-1 Kit for the Preparation of Technetium Tc 99m Mebrofenin 5 in 1 KIT INJECTION, POWDER, LYOPHILIZED, 5 11 45567-0455-1 Kit for the Preparation of Technetium Tc 99m Mebrofenin 10 mL in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 10 11 45567-0455-2 Kit for the Preparation of Technetium Tc 99m Mebrofenin 30 in 1 KIT INJECTION, POWDER, LYOPHILIZED, 30 11 45567-0455-2 Kit for the Preparation of Technetium Tc 99m Mebrofenin 10 mL in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 10 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEBROFENIN ACTIVE INGREDIENT 7PV0B6ED98 KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] 3 MEBROFENIN ACTIVE MOIETY 7PV0B6ED98 KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] 3 STANNOUS FLUORIDE INACTIVE INGREDIENT 3FTR44B32Q KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45567-0455 KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20240907_11492bd5-2ade-4eb4-a23c-b9be99c0d51a.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 Marketing start Marketing end Sample Exclude flag Status 45567-0455-1 45567045501 5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE 2008-01-29 0000-00-00 No No Current 45567-0455-2 45567045502 30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE 2008-01-29 0000-00-00 No No Current