Ceretec

Product NDC: 17156-023
Requested package NDC: 17156-023-05
11-digit product format: 171560023
Labeler code: 17156
Product ID: 17156-023_51e44073-d8b8-4718-be45-b54ac6fc3625
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Exametazime
Dosage form: KIT
Labeler: Medi-Physics Inc.
Application: NDA019829
Marketing category: NDA
Marketing start: 1988-12-30
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17156-023	17156-023-05	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17156-023-05	EA - Each	17156-023	6d4ae813-c184-434d-9559-4308364fdc6a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceretec	TECHNETIUM TC-99M EXAMETAZIME AND COBALTOUS CHLORIDE	Medi-Physics, Inc. dba GE Healthcare	d9c291e0-cd0d-43d2-87b4-defefd531942	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019829 application number: NDA019829
CERETEC	TECHNETIUM TC-99M EXAMETAZIME	Medi-Physics Inc. dba GE Healthcare.	3c1eca7e-57a0-4876-8ed6-cd655ef5e296	2024-01-10	Adverse reactions	Exact identifier application applno (NDA): 019829 application number: NDA019829

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G29272NCKL	EXAMETAZIME	105613-48-7	Exametazime

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17156-023-05	17156002305	1 KIT in 1 CARTON (17156-023-05) * 5 VIAL in 1 TRAY > 4.5 mL in 1 VIAL * 5 VIAL in 1 TRAY > 1 mL in 1 VIAL * 5 VIAL in 1 TRAY (17156-022-05) > 5 mL in 1 VIAL	1 kit	1988-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CERETEC™ N159 Kit for the Preparation of Technetium Tc99m Exametazime Injection	Medi-Physics Inc. \| GE Healthcare AS	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	8