Sodium Nitrite

Product NDC: 60267-311
11-digit product format: 602670311
Labeler code: 60267
Product ID: 60267-311_9d85a469-215e-49ff-9567-c8ef84271d99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Nitrite
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hope Pharmaceuticals
Application: NDA203922
Marketing category: NDA
Marketing start: 2012-02-14
Substance: SODIUM NITRITE
Active strength: 30 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N203922-001	SODIUM NITRITE	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2012-02-14

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28
N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28
N203922-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203922-001	SODIUM NITRITE	300MG/10ML (30MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2012-02-14	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203922-001	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	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203922-001	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	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203922-001	9687506	2030-02-10	U-3395	Drug product	2022-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203922-001	8568793	2031-12-24		Drug substance, Drug product	2013-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203922-001	9687506	2030-02-10	U-3394	Drug product	2022-06-28	`79d66fd596c7…`

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 Nitrite
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM NITRITE	30 mg/mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60267-311-10	Sodium Nitrite	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	10		11
60267-311-10	NITHIODOTE	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	10 mL	30 mg in 1mL	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60267-311-10	ML - Milliliter	60267-311	7d481d76-496d-450c-8d3b-a1178dde2412	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Nitrite	ACTIVE INGREDIENT	M0KG633D4F	SODIUM NITRITE INJECTION, SOLUTION [HOPE PHARMACEUTICALS]	3
Nitrite Ion	ACTIVE MOIETY	J39976L608	SODIUM NITRITE INJECTION, SOLUTION [HOPE PHARMACEUTICALS]	3
Nitrogen	INACTIVE INGREDIENT	N762921K75	SODIUM NITRITE INJECTION, SOLUTION [HOPE PHARMACEUTICALS]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	SODIUM NITRITE INJECTION, SOLUTION [HOPE PHARMACEUTICALS]	3
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
60267-311	SODIUM NITRITE INJECTION, SOLUTION [HOPE PHARMACEUTICALS]	10	Current NDC, Legacy NDC, 1 package rows	20241228_52f01c6e-172a-47a9-98a6-9eab7651a032.zip
60267-311	NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS]	9	Current NDC, Legacy NDC	20241228_ff4941b3-9901-4aab-adcf-c5327bede34e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M0KG633D4F	SODIUM NITRITE	7632-00-0	SODIUM NITRITE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
253010	sodium nitrite 300 MG in 10 ML Injection	PSN	52f01c6e-172a-47a9-98a6-9eab7651a032	11
253010	10 ML sodium nitrite 30 MG/ML Injection	SCD	52f01c6e-172a-47a9-98a6-9eab7651a032	11
253010	sodium nitrite 300 MG per 10 ML Injection	SY	52f01c6e-172a-47a9-98a6-9eab7651a032	11
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 (60267-311-10)	10 ml	2012-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Nitrite	Hope Pharmaceuticals \| Siegfried Grafton, Inc. \| Bora Pharmaceuticals Injectables Inc. \| Pharmaceutics International, Inc.	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	12
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