Ultra-TechneKow

Product NDC: 69945-889
11-digit product format: 699450889
Labeler code: 69945
Product ID: 69945-889_fd425cc0-9f85-4d73-a719-c2f7c418d539
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Technetium Tc-99m
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Curium US LLC
Application: NDA017243
Marketing category: NDA
Marketing start: 2015-12-07
Marketing end: 0000-00-00
Substance: TECHNETIUM TC-99M SODIUM PERTECHNETATE
Active strength: 5 Ci/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69945-889		D	Discontinued by firm		2026-08-10
excluded package	package	69945-889	69945-889-09	D	Discontinued by firm		2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69945-889-09	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69945-889-09	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69945-889-09	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69945-889-09	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69945-889-09	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69945-889-09	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69945-889-09	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69945-889-09	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69945-889-09	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69945-889-09	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69945-889-09	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69945-889-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69945-889-09	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69945-889-09	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69945-889-09	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69945-889-09	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69945-889-09	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69945-889-09	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017243-002	ULTRA-TECHNEKOW V4	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS		Approved before 1982
N017243-003	ULTRA-TECHNEKOW V4	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS		RLD, RS	2014-02-18

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017243-002	ULTRA-TECHNEKOW V4	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017243-003	ULTRA-TECHNEKOW V4	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017243-002	ULTRA-TECHNEKOW V4	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017243-003	ULTRA-TECHNEKOW V4	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017243-002	ULTRA-TECHNEKOW V4	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017243-003	ULTRA-TECHNEKOW V4	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-11-21	Ultra-Technekow ™ DTE (Technetium Tc 99m Generator) Rx only For the Production of Sodium Pertechnetate Tc 99m Injection
2022-01-28	Ultra-Technekow ™ DTE (Technetium Tc 99m Generator) Rx only For the Production of Sodium Pertechnetate Tc 99m Injection
2020-12-10	Ultra-Technekow ™ DTE (Technetium Tc 99m Generator) Rx only For the Production of Sodium Pertechnetate Tc 99m Injection
2020-01-31	Ultra-Technekow ™ DTE (Technetium Tc 99m Generator) Rx only For the Production of Sodium Pertechnetate Tc 99m Injection

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra-Technekow V4	TECHNETIUM TC-99M	Curium US LLC	98947d99-5be5-461e-ad36-7425d3646389	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017243 application number: NDA017243

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A0730CX801	TECHNETIUM TC-99M SODIUM PERTECHNETATE	23288-60-0	TECHNETIUM TC-99M SODIUM PERTECHNETATE
6EW75241VU	TECHNETIUM TC-99M	14133-76-7	Technetium Tc-99m

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69945-889-09	69945088909	1 INJECTION, SOLUTION in 1 CARTON (69945-889-09)	2015-12-07	0000-00-00	No	No	Current