Sodium Iodide I 123

Product NDC
48815-1002
11-digit product format
488151002
Labeler code
48815
Product ID
48815-1002_c07d2306-68cc-4c33-9b6f-4750c0edf625
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Iodide I 123
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Cardinal Health 418, Inc
Application
NDA018671
Marketing category
NDA
Marketing start
2003-01-02
Substance
SODIUM IODIDE I-123
Active strength
200 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018671-001SODIUM IODIDE I 123SODIUM IODIDE I-123100uCiCAPSULE / ORALAARLD, RS1982-05-27
N018671-002SODIUM IODIDE I 123SODIUM IODIDE I-123200uCiCAPSULE / ORALAARLD, RS1982-05-27
N018671-003SODIUM IODIDE I 123SODIUM IODIDE I-123400uCiCAPSULE / ORAL1982-05-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N018671-001AA
N018671-002AA

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018671-002SODIUM IODIDE I 123200uCiCAPSULE / ORALAARLD, RS1982-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018671-003SODIUM IODIDE I 123400uCiCAPSULE / ORAL1982-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018671-001SODIUM IODIDE I 123100uCiCAPSULE / ORALAARLD, RS1982-05-271e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018671-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07N018671-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018671-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018671-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018671-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018671-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018671-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018671-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018671-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018671-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018671-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018671-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018671-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018671-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018671-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018671-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018671-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018671-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018671-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018671-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018671-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018671-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018671-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018671-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018671-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018671-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018671-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018671-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018671-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018671-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018671-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018671-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018671-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018671-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018671-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018671-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018671-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018671-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018671-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018671-002AA1bb7c543d1eb4…

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-123200 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
50415c27-1928-4307-b1dc-648f47edf65dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48815-1002-1Sodium Iodide I 1231 in 1 VIAL, PLASTICCAPSULE, GELATIN COATED13
48815-1002-1Sodium Iodide I 1231 in 1 CANCAPSULE, GELATIN COATED13
48815-1002-5Sodium Iodide I 1235 in 1 VIAL, PLASTICCAPSULE, GELATIN COATED53
48815-1002-5Sodium Iodide I 1231 in 1 CANCAPSULE, GELATIN COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48815-1002-1EA - Each48815-10023df0358a-1d23-4aad-81fd-028f768b27eb12020-01-03
48815-1002-5EA - Each48815-1002eb7ae9ac-91a7-497a-9519-de1e3896610212020-01-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48815-1002SODIUM IODIDE I 123 CAPSULE, GELATIN COATED [CARDINAL HEALTH 418, INC]3Current NDC, Legacy NDC, 4 package rows20180418_50415c27-1928-4307-b1dc-648f47edf65d.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 123Cardinal Health 418, Inc50415c27-1928-4307-b1dc-648f47edf65d2018-04-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 018671
application number: NDA018671
ndc (product): 48815-1002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48815-1002-1488151002011 VIAL, PLASTIC in 1 CAN (48815-1002-1) / 1 CAPSULE, GELATIN COATED in 1 VIAL, PLASTIC2003-01-020000-00-00NoNoCurrent
48815-1002-5488151002051 VIAL, PLASTIC in 1 CAN (48815-1002-5) / 5 CAPSULE, GELATIN COATED in 1 VIAL, PLASTIC2003-01-020000-00-00NoNoCurrent