Ultra-Technekow

Product NDC
69945-051
11-digit product format
699450051
Labeler code
69945
Product ID
69945-051_249a6bf5-7d15-3b75-e063-6394a90af09f
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
2014-06-10
Substance
TECHNETIUM TC-99M SODIUM PERTECHNETATE
Active strength
5 Ci/1
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017243-002ULTRA-TECHNEKOW V4TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982
N017243-003ULTRA-TECHNEKOW V4TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017243-002ULTRA-TECHNEKOW V40.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017243-003ULTRA-TECHNEKOW V41-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017243-002ULTRA-TECHNEKOW V40.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017243-003ULTRA-TECHNEKOW V41-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N017243-002ULTRA-TECHNEKOW V40.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017243-003ULTRA-TECHNEKOW V41-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017243-002ULTRA-TECHNEKOW FM0.25-3 CI/GENERATORSOLUTION / INTRAVENOUSApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N017243-003ULTRA-TECHNEKOW FM1-19 CI/GENERATORSOLUTION / INTRAVENOUSRLD, RS2014-02-18782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra-Technekow
Brand name suffix
V4
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TECHNETIUM TC-99M SODIUM PERTECHNETATE5 Ci/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A0730CX801Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98947d99-5be5-461e-ad36-7425d3646389Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
72f9a243-5540-436e-9d14-246b7fd7ad32Product name220260112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69945-051-09Ultra-TechnekowV41 in 1 CARTONINJECTION, SOLUTION114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TECHNETIUM TC-99M SODIUM PERTECHNETATEACTIVE INGREDIENTA0730CX801ULTRA-TECHNEKOW V4 (TECHNETIUM TC-99M) INJECTION, SOLUTION [MALLINCKRODT NUCLEAR MEDICINE LLC]1
TECHNETIUM TC-99M PERTECHNETATEACTIVE MOIETYPPP8783IQ1ULTRA-TECHNEKOW V4 (TECHNETIUM TC-99M) INJECTION, SOLUTION [MALLINCKRODT NUCLEAR MEDICINE LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69945-051ULTRA-TECHNEKOW V4 (TECHNETIUM TC-99M) INJECTION, SOLUTION [CURIUM US LLC]14Current NDC, Legacy NDC, 1 package rows20241019_98947d99-5be5-461e-ad36-7425d3646389.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra-Technekow V4TECHNETIUM TC-99MCurium US LLC98947d99-5be5-461e-ad36-7425d36463892024-10-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 017243
application number: NDA017243
ndc (product): 69945-051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69945-051-09699450051091 INJECTION, SOLUTION in 1 CARTON (69945-051-09) 2014-06-100000-00-00NoNoCurrent