Ceretec

Product NDC
17156-025
11-digit product format
171560025
Labeler code
17156
Product ID
17156-025_644e5fd7-d8ee-4f20-aa05-9a11332f08c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Technetium Tc-99m Exametazime and Cobaltous Chloride
Dosage form
KIT
Labeler
Medi-Physics, Inc. dba GE Healthcare
Application
NDA019829
Marketing category
NDA
Marketing start
2018-09-25
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019829-001CERETECTECHNETIUM TC-99M EXAMETAZIME KITN/AINJECTABLE / INJECTIONRLD, RS1988-12-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-303f01610625f2…
2019-09-15 20:21 UTC2019-09N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019829-001CERETECN/AINJECTABLE / INJECTIONRLD, RS1988-12-30e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Ceretec
Listing expiration
2026-12-31

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9c291e0-cd0d-43d2-87b4-defefd531942Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2265993-8bd7-4a7d-bf41-09c31b647f03Product name120230719

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17156-025-05Ceretec1 in 1 CARTONKIT13
17156-027-01Ceretec2.5 mL in 1 VIAL, GLASSINJECTION, SOLUTION12.5 mL200 ug in 2mL3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17156-025-05EA - Each17156-025bd2d9853-4728-4541-ac78-ac15785acd2e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17156-025CERETEC (TECHNETIUM TC-99M EXAMETAZIME AND COBALTOUS CHLORIDE) KIT [MEDI-PHYSICS, INC. DBA GE HEALTHCARE]3Current NDC, Legacy NDC, 2 package rows20240120_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CeretecTECHNETIUM TC-99M EXAMETAZIME AND COBALTOUS CHLORIDEMedi-Physics, Inc. dba GE Healthcared9c291e0-cd0d-43d2-87b4-defefd5319422024-01-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019829
application number: NDA019829
ndc (product): 17156-025
CERETECTECHNETIUM TC-99M EXAMETAZIMEMedi-Physics Inc. dba GE Healthcare.3c1eca7e-57a0-4876-8ed6-cd655ef5e2962024-01-10Adverse reactionsExact identifier
application applno (NDA): 019829
application number: NDA019829

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17156-025-05171560025051 KIT in 1 CARTON (17156-025-05) * 5 mL in 1 VIAL, GLASS (17156-022-05) * 2.5 mL in 1 VIAL, GLASS (17156-027-01) 1 kit2018-09-250000-00-00NoNoCurrent
17156-027-01171560027012.5 mL in 1 VIAL, GLASS2.5 mlHistorical