CERETEC

Product NDC: 17156-022
Requested package NDC: 17156-022-05
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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019829-001	CERETEC	N/A	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3c1eca7e-57a0-4876-8ed6-cd655ef5e296	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f2265993-8bd7-4a7d-bf41-09c31b647f03	Product name	1	20230719

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17156-022-05	EA - Each	17156-022	1e98663d-3510-421b-a65f-11624a2f2dea	1	2019-06-19

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
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.

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 ndc (package): 17156-022-05 ndc11 (package): 17156002205
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 ndc (package): 17156-022-05 ndc (product): 17156-022 ndc11 (package): 17156002205

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3B744AG22N	TECHNETIUM TC-99M EXAMETAZIME	99944-78-2	TECHNETIUM TC-99M EXAMETAZIME

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17156-022-05	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

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
Ceretec™ N109A Kit for the Preparation of Technetium Tc99m Exametazime Injection	Medi-Physics Inc. dba GE Healthcare. \| GE Healthcare AS	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	7
Ceretec	Medi-Physics, Inc. dba GE Healthcare \| GE Healthcare AS	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	3