Application 021305

Type: NDA
Sponsor: JUBILANT DRAXIMAGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	HICON	SODIUM IODIDE I-131	SOLUTION;ORAL	1-250mCi/0.25ML	No	No
003	HICON	SODIUM IODIDE I-131	SOLUTION;ORAL	1-500mCi/0.5ML	No	No
004	SODIUM IODIDE I 131	SODIUM IODIDE I-131	CAPSULE;ORAL	2-200mCi	No	No
005	HICON	SODIUM IODIDE I-131	SOLUTION;ORAL	1-1000mCi/ML	No	No
006	SODIUM IODIDE I 131	SODIUM IODIDE I-131	CAPSULE;ORAL	0.009-0.1mCi	Yes	No
007	HICON	SODIUM IODIDE I-131	SOLUTION;ORAL	250-1000mCi	Yes	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…`

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 ndc (product): 65174-880
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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65174-461	Sodium Iodide I 131 Diagnostic	Sodium Iodide I 131	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current
65174-461	Sodium Iodide I 131 Diagnostic	Sodium Iodide I 131	Jubilant DraxImage Inc.	NDA	Current
65174-461	Sodium Iodide I 131 Diagnostic	Sodium Iodide I 131	Jubilant DraxImage Inc.	NDA	Current
65174-461	Sodium Iodide I 131 Diagnostic	Sodium Iodide I 131	Jubilant DraxImage Inc.	NDA	Current
65174-461	Sodium Iodide I 131 Diagnostic	Sodium Iodide I 131	Jubilant DraxImage Inc.	NDA	Current
65174-880	HICON	Sodium Iodide I 131	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current
65174-880	HICON	Sodium Iodide I 131	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current
65174-880	HICON	Sodium Iodide I 131	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current
65174-880	HICON	Sodium Iodide I 131	Jubilant DraxImage Inc.	NDA	Current
65174-880	HICON	Sodium Iodide I 131	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67797	SUPPL	2021-06-15
67773	SUPPL	2021-06-14
4988	SUPPL	2016-07-12
15155	SUPPL	2016-06-21
4987	SUPPL	2016-06-21
4986	SUPPL	2011-10-05
15154	SUPPL	2011-10-03
36627	SUPPL	2011-09-29
27434	SUPPL	2011-09-28
36626	SUPPL	2008-03-05
4985	SUPPL	2008-03-04
27433	SUPPL	2007-04-25
36625	SUPPL	2007-04-20
4984	SUPPL	2006-10-26
27432	SUPPL	2006-01-20
15153	SUPPL	2006-01-10
15152	SUPPL	2005-05-20
4983	SUPPL	2005-05-20
4982	SUPPL	2004-12-02
4981	SUPPL	2003-08-15
21587	ORIG	2003-06-26
15151	ORIG	2003-01-24
4980	ORIG	2003-01-24