Home NDC 45567-0060 Kit for the Preparation of Technetium Tc99m Pyrophosphate
Product NDC 45567-0060
11-digit product format 455670060
Labeler code 45567
Product ID 45567-0060_3010b45e-eed1-a5d0-e063-6294a90a40cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name technetium tc99m pyrophosphate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA019039
Marketing category NDA
Marketing start 1987-06-30
Substance TECHNETIUM TC-99M PYROPHOSPHATE
Active strength 12 mg/10mL
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 N019039-001 CIS-PYRO TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A INJECTABLE / INJECTION AP 1987-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019039-001 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 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019039-001 CIS-PYRO N/A INJECTABLE / INJECTION AP 1987-06-30 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 Tc99m Pyrophosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECHNETIUM TC-99M PYROPHOSPHATE 12 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5L76I61H2B 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 45567-0060-1 Kit for the Preparation of Technetium Tc99m Pyrophosphate 5 in 1 KIT INJECTION 5 9 45567-0060-1 Kit for the Preparation of Technetium Tc99m Pyrophosphate 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 9 45567-0060-2 Kit for the Preparation of Technetium Tc99m Pyrophosphate 30 in 1 KIT INJECTION 30 9 45567-0060-2 Kit for the Preparation of Technetium Tc99m Pyrophosphate 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45567-0060 KIT FOR THE PREPARATION OF TECHNETIUM TC99M PYROPHOSPHATE (TECHNETIUM TC99M PYROPHOSPHATE) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 9 Current NDC, Legacy NDC, 4 package rows 20250412_1f0cbd23-2fb3-43b7-b8af-7de246151149.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 45567-0060-1 45567006001 5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE 1987-06-30 0000-00-00 No No Current 45567-0060-2 45567006002 30 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 10 mL in 1 VIAL, MULTI-DOSE 1987-06-30 0000-00-00 No No Current