Sodium Iodide I 131 Diagnostic

Product NDC: 65174-461
11-digit product format: 651740461
Labeler code: 65174
Product ID: 65174-461_6dfea844-f0a4-4485-b898-399267cccc2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Iodide I 131
Dosage form: CAPSULE
Route: ORAL
Labeler: Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application: NDA021305
Marketing category: NDA
Marketing start: 2006-05-01
Substance: SODIUM IODIDE I-131
Active strength: 100 mCi/1
Pharmacologic classes: Radioactive Therapeutic Agent [EPC], Radiopharmaceutical Activity [MoA]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021305-002	HICON	SODIUM IODIDE I-131	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24
N021305-003	HICON	SODIUM IODIDE I-131	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24
N021305-004	SODIUM IODIDE I 131	SODIUM IODIDE I-131	2-200mCi	CAPSULE / ORAL			2004-11-18
N021305-005	HICON	SODIUM IODIDE I-131	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04
N021305-006	SODIUM IODIDE I 131	SODIUM IODIDE I-131	0.009-0.1mCi	CAPSULE / ORAL		RLD	2005-05-19
N021305-007	HICON	SODIUM IODIDE I-131	250-1000mCi	SOLUTION / ORAL	AA	RLD, RS	2011-12-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021305-007	AA

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021305-002	HICON	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021305-003	HICON	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021305-004	SODIUM IODIDE I 131	2-200mCi	CAPSULE / ORAL			2004-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021305-005	HICON	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021305-006	SODIUM IODIDE I 131	0.009-0.1mCi	CAPSULE / ORAL		RLD	2005-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021305-007	HICON	250-1000mCi	SOLUTION / ORAL	AA	RLD, RS	2011-12-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021305-002	HICON	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021305-003	HICON	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021305-004	SODIUM IODIDE I 131	2-200mCi	CAPSULE / ORAL			2004-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021305-005	HICON	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021305-006	SODIUM IODIDE I 131	0.009-0.1mCi	CAPSULE / ORAL		RLD	2005-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021305-007	HICON	250-1000mCi	SOLUTION / ORAL	AA	RLD, RS	2011-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021305-002	HICON	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021305-003	HICON	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021305-004	SODIUM IODIDE I 131	2-200mCi	CAPSULE / ORAL			2004-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021305-005	HICON	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021305-006	SODIUM IODIDE I 131	0.009-0.1mCi	CAPSULE / ORAL		RLD	2005-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021305-007	HICON	250-1000mCi	SOLUTION / ORAL	AA	RLD, RS	2011-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021305-002	HICON	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021305-003	HICON	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021305-004	SODIUM IODIDE I 131	2-200mCi	CAPSULE / ORAL			2004-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021305-005	HICON	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021305-006	SODIUM IODIDE I 131	0.009-0.1mCi	CAPSULE / ORAL		RLD	2005-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021305-007	HICON	250-1000mCi	SOLUTION / ORAL	AA	RLD, RS	2011-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021305-002	HICON	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021305-003	HICON	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021305-004	SODIUM IODIDE I 131	2-200mCi	CAPSULE / ORAL			2004-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021305-005	HICON	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021305-006	SODIUM IODIDE I 131	0.009-0.1mCi	CAPSULE / ORAL		RLD	2005-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021305-007	HICON	250-1000mCi	SOLUTION / ORAL	AA	RLD, RS	2011-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021305-002	HICON	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021305-003	HICON	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021305-004	SODIUM IODIDE I 131	2-200mCi	CAPSULE / ORAL			2004-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021305-005	HICON	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021305-006	SODIUM IODIDE I 131	0.009-0.1mCi	CAPSULE / ORAL		RLD	2005-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021305-007	HICON	250-1000mCi	SOLUTION / ORAL	AA	RLD, RS	2011-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021305-002	HICON	1-250mCi/0.25ML	SOLUTION / ORAL			2003-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021305-003	HICON	1-500mCi/0.5ML	SOLUTION / ORAL			2003-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021305-004	SODIUM IODIDE I 131	2-200mCi	CAPSULE / ORAL			2004-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021305-005	HICON	1-1000mCi/ML	SOLUTION / ORAL			2006-04-04	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021305-007	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021305-007	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021305-007	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021305-007	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021305-007	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021305-007	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021305-007	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021305-007	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021305-007	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021305-007	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021305-007	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021305-007	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021305-007	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021305-007	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021305-007	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021305-007	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021305-007	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021305-007	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021305-007	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021305-007	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021305-007	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021305-007	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021305-007	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021305-007	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021305-007	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021305-007	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021305-007	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021305-007	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021305-007	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021305-007	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021305-007	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021305-007	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021305-007	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021305-007	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021305-007	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021305-007	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021305-007	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021305-007	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021305-007	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sodium Iodide I 131 Diagnostic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM IODIDE I-131	100 mCi/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
29VCO8ACHH	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
46b8d7ba-432d-d610-84f2-550bf9d0bae3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
20ce01ac-ad85-424c-96b9-52d2671eb5b5	Product name	1	20200617
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65174-461-05	Sodium Iodide I 131 Diagnostic	5 in 1 VIAL	CAPSULE	5		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65174-461-05	EA - Each	65174-461	470e92af-3543-42ab-a6ec-455dd51aafba	1	2024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Iodide I-131	ACTIVE INGREDIENT	29VCO8ACHH	SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131) CAPSULE [JUBILANT DRAXIMAGE INC.]	1
Iodide I-131	ACTIVE MOIETY	I5X6L61HUT	SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131) CAPSULE [JUBILANT DRAXIMAGE INC.]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131) CAPSULE [JUBILANT DRAXIMAGE INC.]	1
Sodium Phosphate, Dibasic Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131) CAPSULE [JUBILANT DRAXIMAGE INC.]	1
Sodium Thiosulfate	INACTIVE INGREDIENT	HX1032V43M	SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131) CAPSULE [JUBILANT DRAXIMAGE INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65174-461	SODIUM IODIDE I 131 DIAGNOSTIC (SODIUM IODIDE I 131) CAPSULE [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]	6	Current NDC, Legacy NDC, 1 package rows	20200826_46b8d7ba-432d-d610-84f2-550bf9d0bae3.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HICON	SODIUM IODIDE I 131	Jubilant DraxImage Inc., dba Jubilant Radiopharma	524a0dac-6e2b-2c0c-04b4-76d85dba63c5	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021305 application number: NDA021305
Sodium Iodide I 131 Diagnostic	SODIUM IODIDE I 131	Jubilant DraxImage Inc., dba Jubilant Radiopharma	46b8d7ba-432d-d610-84f2-550bf9d0bae3	2020-08-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021305 application number: NDA021305 ndc (product): 65174-461

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
29VCO8ACHH	SODIUM IODIDE I-131	7790-26-3	SODIUM IODIDE I-131

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65174-461-05	65174046105	5 CAPSULE in 1 VIAL (65174-461-05)	5 capsule	2006-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Iodide I 131 Diagnostic	Jubilant DraxImage Inc., dba Jubilant Radiopharma	2020-08-25	HUMAN PRESCRIPTION DRUG LABEL	6