Home NDC 45567-0655-1 Kit for the Preparation of Technetium Tc99m Mertiatide
Product NDC 45567-0655
Requested package NDC 45567-0655-1
11-digit product format 455670655
Labeler code 45567
Product ID 45567-0655_21ca1be3-2caf-535c-e063-6394a90a18e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betiatide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA208994
Marketing category ANDA
Marketing start 2019-09-02
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 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 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT TECHNETIUM TC-99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208994-001 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.
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 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208994-001 TECHNETIUM TC99M MERTIATIDE KIT N/A INJECTABLE / INJECTION AP 2019-07-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Kit for the Preparation of Technetium Tc99m 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 45567-0655-1 Kit for the Preparation of Technetium Tc99m 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 45567-0655 KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE (BETIATIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240912_0ad62039-f848-4f3d-b489-2524e6b6b86e.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 45567-0655-1 45567065501 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1) 2019-09-02 0000-00-00 No No Current