Ultratag

Product NDC: 69945-068
11-digit product format: 699450068
Labeler code: 69945
Product ID: 69945-068_38f35892-fad5-8465-e063-6294a90a32a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Kit for the Preparation of Technetium Tc 99m Red Blood Cells
Dosage form: KIT
Labeler: Curium US LLC
Application: NDA019981
Marketing category: NDA
Marketing start: 1991-06-10
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-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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ultratag
Brand name suffix: RBC
Listing expiration: 2026-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9f999b75-8a66-40bf-9352-478850b41225	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69945-068-10	UltratagRBC	1 in 1 CELLO PACK	KIT	1		17
69945-068-20	UltratagRBC	5 in 1 BOX	KIT	5		17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STANNOUS CHLORIDE	ACTIVE INGREDIENT	1BQV3749L5	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2
STANNOUS CATION	ACTIVE MOIETY	QI30938BMS	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2
SODIUM HYPOCHLORITE	INACTIVE INGREDIENT	DY38VHM5OD	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ULTRATAG RBC (TECHNETIUM TC 99M-LABELED RED BLOOD CELLS) KIT [MALLINCKRODT NUCLEAR MEDICINE LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69945-068	ULTRATAG RBC (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M RED BLOOD CELLS) KIT [CURIUM US LLC]	15	Current NDC, Legacy NDC, 2 package rows	20240719_9f999b75-8a66-40bf-9352-478850b41225.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 · 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69945-068-10	69945006810	1 in 1 CELLO PACK						Historical
69945-068-20	69945006820	5 CELLO PACK in 1 BOX (69945-068-20) / 1 KIT in 1 CELLO PACK (69945-068-10) * .6 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASS * 9.5 mg in 1 VIAL, GLASS	5 cello pack	1991-06-10	0000-00-00	No	No	Current