SODIUM IODIDE I 123

Product NDC
69945-601
11-digit product format
699450601
Labeler code
69945
Product ID
69945-601_24b19127-9a67-0ddf-e063-6394a90ae0b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium iodide i 123
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Curium US LLC
Application
ANDA071909
Marketing category
ANDA
Marketing start
2015-11-04
Substance
SODIUM IODIDE I-123
Active strength
100 uCi/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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071909-001SODIUM IODIDE I 123SODIUM IODIDE I-123100uCiCAPSULE / ORALAA1989-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A071909-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-283f01610625f2…
2019-09-15 20:21 UTC2019-09A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071909-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAA1989-02-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071909-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071909-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071909-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071909-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071909-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071909-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071909-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071909-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071909-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071909-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071909-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071909-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071909-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071909-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071909-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071909-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071909-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071909-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071909-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071909-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071909-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071909-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A071909-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071909-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071909-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071909-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A071909-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071909-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071909-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071909-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071909-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071909-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071909-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071909-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071909-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071909-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071909-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071909-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071909-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071909-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM IODIDE I 123
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM IODIDE I-123100 uCi/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
29UKX3A616Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
493fa2ab-4eb0-4434-9739-3079b2f0e272Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69945-601-10SODIUM IODIDE I 1231 in 1 CANCAPSULE, GELATIN COATED110
69945-601-10SODIUM IODIDE I 1231 in 1 BOTTLECAPSULE, GELATIN COATED110

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69945-601SODIUM IODIDE I 123 CAPSULE, GELATIN COATED [CURIUM US LLC]10Current NDC, Legacy NDC, 2 package rows20241019_493fa2ab-4eb0-4434-9739-3079b2f0e272.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
SODIUM IODIDE I 123SODIUM IODIDE I 123Curium US LLC493fa2ab-4eb0-4434-9739-3079b2f0e2722024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071909
application number: ANDA071909
ndc (product): 69945-601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69945-601-10699450601101 BOTTLE in 1 CAN (69945-601-10) / 1 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2015-11-040000-00-00NoNoCurrent