Application 019981

Type: NDA
Sponsor: CURIUM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRATAG	TECHNETIUM TC-99M RED BLOOD CELL KIT	INJECTABLE;INJECTION	N/A	Yes	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
N019981-001	ULTRATAG	TECHNETIUM TC-99M RED BLOOD CELL KIT	N/A	INJECTABLE / INJECTION		RLD, RS	1991-06-10

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	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019981-001	ULTRATAG	N/A	INJECTABLE / INJECTION	RLD, RS	1991-06-10	`e64feba35796…`

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
Ultratag RBC	KIT FOR THE PREPARATION OF TECHNETIUM TC 99M RED BLOOD CELLS	Curium US LLC	9f999b75-8a66-40bf-9352-478850b41225	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019981 application number: NDA019981 ndc (product): 69945-068

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69945-068	Ultratag	Technetium Tc 99m-Labeled Red Blood Cells	Curium US LLC	NDA	Current
69945-068	Ultratag	Technetium Tc 99m-Labeled Red Blood Cells	Curium US LLC	NDA	Current
69945-068	Ultratag	Technetium Tc 99m-Labeled Red Blood Cells	Curium US LLC	NDA	Current