Home NDC 17156-022 CERETEC
Product NDC 17156-022
11-digit product format 171560022
Labeler code 17156
Product ID 17156-022_87cca989-b750-4ca7-9b5a-6f00d0457c46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TECHNETIUM TC-99M EXAMETAZIME
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Medi-Physics Inc. dba GE Healthcare.
Application NDA019829
Marketing category NDA
Marketing start 1988-12-30
Substance TECHNETIUM TC-99M EXAMETAZIME
Active strength .5 mg/5mL
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 N019829-001 CERETEC TECHNETIUM TC-99M EXAMETAZIME KIT N/A INJECTABLE / INJECTION RLD, RS 1988-12-30
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.
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 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019829-001 CERETEC N/A INJECTABLE / INJECTION RLD, RS 1988-12-30 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base CERETEC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECHNETIUM TC-99M EXAMETAZIME .5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3B744AG22N 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 17156-022-05 CERETEC 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 7 17156-022-05 CERETEC 5 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 5 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Technetium Tc-99m Exametazime ACTIVE INGREDIENT 3B744AG22N CERETEC (EXAMETAZIME) KIT [MEDI-PHYSICS INC.] 6 TECHNETIUM TC-99M ACTIVE MOIETY 6EW75241VU CERETEC (EXAMETAZIME) KIT [MEDI-PHYSICS INC.] 6 Nitrogen INACTIVE INGREDIENT N762921K75 CERETEC (EXAMETAZIME) KIT [MEDI-PHYSICS INC.] 6 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X CERETEC (EXAMETAZIME) KIT [MEDI-PHYSICS INC.] 6 Stannous Chloride INACTIVE INGREDIENT 1BQV3749L5 CERETEC (EXAMETAZIME) KIT [MEDI-PHYSICS INC.] 6 TECHNETIUM TC-99M EXAMETAZIME ACTIVE INGREDIENT 3B744AG22N CERETEC (TECHNETIUM TC-99M EXAMETAZIME) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] 5 TECHNETIUM TC-99M EXAMETAZIME ACTIVE MOIETY 3B744AG22N CERETEC (TECHNETIUM TC-99M EXAMETAZIME) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] 5 Nitrogen INACTIVE INGREDIENT N762921K75 CERETEC (TECHNETIUM TC-99M EXAMETAZIME) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] 5 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X CERETEC (TECHNETIUM TC-99M EXAMETAZIME) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] 5 Stannous Chloride INACTIVE INGREDIENT 1BQV3749L5 CERETEC (TECHNETIUM TC-99M EXAMETAZIME) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17156-022 CERETEC (TECHNETIUM TC-99M EXAMETAZIME) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] 7 Current NDC, Legacy NDC, 2 package rows 20240112_3c1eca7e-57a0-4876-8ed6-cd655ef5e296.zip 17156-022 CERETEC (TECHNETIUM TC-99M EXAMETAZIME AND COBALTOUS CHLORIDE) KIT [MEDI-PHYSICS, INC. DBA GE HEALTHCARE] 3 Current NDC, Legacy NDC 20240120_d9c291e0-cd0d-43d2-87b4-defefd531942.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 · 2 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 17156-022-05 17156002205 5 VIAL in 1 TRAY (17156-022-05) / 5 mL in 1 VIAL 5 vial 1988-12-30 0000-00-00 No No Current