NITHIODOTE

Product NDC: 60267-812
11-digit product format: 602670812
Labeler code: 60267
Product ID: 60267-812_74809468-0182-485a-bf62-e09489756a36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Nitrite and Sodium Thiosulfate
Dosage form: KIT
Labeler: Hope Pharmaceuticals
Application: NDA201444
Marketing category: NDA
Marketing start: 2011-01-14
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201444-001	NITHIODOTE	SODIUM NITRITE; SODIUM THIOSULFATE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS		RLD, RS	2011-01-14

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12
N201444-001	12304813	2030-02-10		Drug product	2025-05-22
N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29
N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29
N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29
N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06
N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06
N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02
N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201444-001	NITHIODOTE	300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)	SOLUTION, SOLUTION / INTRAVENOUS, INTRAVENOUS	RLD, RS	2011-01-14	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 281 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	12304813	2030-02-10		Drug product	2025-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	9345724	2030-07-07	U-2015	Drug substance, Drug product	2017-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	9585912	2030-07-07		Drug substance, Drug product	2017-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	8496973	2031-03-29	U-1419	Drug substance, Drug product	2013-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201444-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201444-001	11753301	2030-02-10	U-3681	Drug substance, Drug product	2023-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201444-001	9687506	2030-02-10	U-3394	Drug product	2022-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201444-001	9687506	2030-02-10	U-3395	Drug product	2022-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201444-001	10479686	2030-07-07	U-3390	Drug product	2022-06-29	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: NITHIODOTE
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237832	Internal RxNorm lookup
253010	Internal RxNorm lookup
1086835	Internal RxNorm lookup
1086836	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ff4941b3-9901-4aab-adcf-c5327bede34e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
70dd82cf-c501-052d-5d98-d42ef9849750	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-02-07	These highlights do not include all the information needed to use the NITHIODOTE safely and effectively. See full prescribing information for NITHIODOTE. NITHIODOTE (sodium nitrite injection and sodium thiosulfate injection for intravenous infusion). Initial U.S. Approval: 1992
2020-02-07	These highlights do not include all the information needed to use the NITHIODOTE safely and effectively. See full prescribing information for NITHIODOTE. NITHIODOTE (sodium nitrite injection and sodium thiosulfate injection for intravenous infusion). Initial U.S. Approval: 1992
2020-01-31	These highlights do not include all the information needed to use the NITHIODOTE safely and effectively. See full prescribing information for NITHIODOTE. NITHIODOTE (sodium nitrite injection and sodium thiosulfate injection for intravenous infusion). Initial U.S. Approval: 1992
2020-01-31	These highlights do not include all the information needed to use the NITHIODOTE safely and effectively. See full prescribing information for NITHIODOTE. NITHIODOTE (sodium nitrite injection and sodium thiosulfate injection for intravenous infusion). Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60267-311-10	NITHIODOTE	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	10 mL	30 mg in 1mL	10
60267-705-50	NITHIODOTE	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	50 mL	250 mg in 1mL	10
60267-812-00	NITHIODOTE	1 in 1 CARTON	KIT	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60267-812-00	ML - Milliliter	60267-812	e69c10b0-705e-4bea-8055-3f4f8b62bc1a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Nitrite	ACTIVE INGREDIENT	M0KG633D4F	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	1
Sodium Thiosulfate	ACTIVE INGREDIENT	HX1032V43M	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	1
Sodium Cation	ACTIVE MOIETY	LYR4M0NH37	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	1
Boric Acid	INACTIVE INGREDIENT	R57ZHV85D4	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	1
Potassium Chloride	INACTIVE INGREDIENT	660YQ98I10	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60267-812	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 3 package rows	20241228_ff4941b3-9901-4aab-adcf-c5327bede34e.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITHIODOTE	SODIUM NITRITE AND SODIUM THIOSULFATE	Hope Pharmaceuticals	ff4941b3-9901-4aab-adcf-c5327bede34e	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 201444 application number: NDA201444 ndc (product): 60267-812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086836	{1 (10 ML sodium nitrite 30 MG/ML Injection) / 1 (50 ML sodium thiosulfate 250 MG/ML Injection) } Pack [Nithiodote]	BPCK	ff4941b3-9901-4aab-adcf-c5327bede34e	10
1086835	{1 (10 ML sodium nitrite 30 MG/ML Injection) / 1 (50 ML sodium thiosulfate 250 MG/ML Injection) } Pack	GPCK	ff4941b3-9901-4aab-adcf-c5327bede34e	10
1086836	Nithiodote Pack	PSN	ff4941b3-9901-4aab-adcf-c5327bede34e	10
253010	sodium nitrite 300 MG in 10 ML Injection	PSN	ff4941b3-9901-4aab-adcf-c5327bede34e	10
1086835	sodium nitrite 300 MG in 10 ML Injection / sodium thiosulfate 12.5 GM in 50 ML Injection Pack	PSN	ff4941b3-9901-4aab-adcf-c5327bede34e	10
237832	sodium thiosulfate 12.5 GM in 50 ML Injection	PSN	ff4941b3-9901-4aab-adcf-c5327bede34e	10
253010	10 ML sodium nitrite 30 MG/ML Injection	SCD	ff4941b3-9901-4aab-adcf-c5327bede34e	10
237832	50 ML sodium thiosulfate 250 MG/ML Injection	SCD	ff4941b3-9901-4aab-adcf-c5327bede34e	10
1086836	Nithiodote Kit	SY	ff4941b3-9901-4aab-adcf-c5327bede34e	10
1086835	sodium nitrite 300 MG per 10 ML / sodium thiosulfate 12.5 GM per 50 ML Injection Kit	SY	ff4941b3-9901-4aab-adcf-c5327bede34e	10
253010	sodium nitrite 300 MG per 10 ML Injection	SY	ff4941b3-9901-4aab-adcf-c5327bede34e	10
237832	sodium thiosulfate 12.5 GM per 50 ML Injection	SY	ff4941b3-9901-4aab-adcf-c5327bede34e	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60267-311-10	60267031110	10 mL in 1 VIAL, SINGLE-USE	10 ml					Historical
60267-705-50	60267070550	50 mL in 1 VIAL, SINGLE-DOSE	50 ml					Historical
60267-812-00	60267081200	1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50)	1 kit	2011-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITHIODOTE	Hope Pharmaceuticals \| Siegfried Grafton, Inc. \| Bora Pharmaceuticals Injectables Inc. \| Sterling Wisconsin LLC \| Curia New York, Inc.	2025-10-06	HUMAN PRESCRIPTION DRUG LABEL	10