NIPRIDE RTU

Product NDC: 51754-1018
11-digit product format: 517541018
Labeler code: 51754
Product ID: 51754-1018_ed0040fb-c481-4477-8712-00fa6350cd70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Nitroprusside
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: EXELA PHARMA SCIENCES, LLC
Application: NDA209387
Marketing category: NDA
Marketing start: 2018-02-09
Marketing end: 2019-08-30
Substance: SODIUM NITROPRUSSIDE
Active strength: 0 mg/mL
Pharmacologic classes: Vasodilation [PE],Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51754-1018		D	Discontinued by firm		2026-08-11
excluded package	package	51754-1018	51754-1018-1	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51754-1018-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51754-1018-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51754-1018-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51754-1018-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51754-1018-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51754-1018-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51754-1018-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51754-1018-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51754-1018-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51754-1018-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51754-1018-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51754-1018-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	SODIUM NITROPRUSSIDE	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08
N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	SODIUM NITROPRUSSIDE	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07
N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	SODIUM NITROPRUSSIDE	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209387-001	AP
N209387-003	AP

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 · 123 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
2026-02-19 14:30 UTC	2026-02	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209387-002	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2017-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209387-003	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	20MG/100ML (0.2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209387-001	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	50MG/100ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209387-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209387-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209387-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209387-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209387-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209387-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209387-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209387-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209387-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209387-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209387-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209387-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209387-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209387-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209387-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209387-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209387-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209387-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209387-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209387-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209387-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209387-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209387-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209387-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209387-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209387-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209387-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209387-003	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209387-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209387-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209387-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N209387-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209387-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N209387-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209387-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209387-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209387-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209387-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209387-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209387-003	AP	1	`a67488948f0b…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baa2d9bb-fc02-4e7a-afa2-38f3bd0d9f47	Product name	2	20230501
374f859f-b175-4ec0-a0a3-35bda0517e25	Product name	9	20200522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51754-1018-1	NIPRIDE RTU	50 mL in 1 VIAL	INJECTION, SOLUTION	50		6
51754-1018-1	NIPRIDE RTU	1 in 1 VIAL	INJECTION, SOLUTION	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51754-1018-1	ML - Milliliter	51754-1018	d5fbe19d-c7f6-48d7-b26f-585647a9f140	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51754-1018	NIPRIDE RTU (SODIUM NITROPRUSSIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]	6	Legacy NDC, 2 package rows	20190607_5acf0836-93ff-4064-b888-3f560e8a558d.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
NIPRIDE RTU	SODIUM NITROPRUSSIDE	EXELA PHARMA SCIENCES, LLC	5acf0836-93ff-4064-b888-3f560e8a558d	2018-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209387 application number: NDA209387 ndc (product): 51754-1018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EAO03PE1TC	SODIUM NITROPRUSSIDE	13755-38-9	SODIUM NITROPRUSSIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1999187	NIPRIDE RTU 10 MG in 50 ML Injection	PSN	5acf0836-93ff-4064-b888-3f560e8a558d	6
2052424	NIPRIDE RTU 20 MG in 100 mL Injection	PSN	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876373	NIPRIDE RTU 50 MG in 100 ML Injection	PSN	5acf0836-93ff-4064-b888-3f560e8a558d	6
1999185	sodium nitroprusside 10 MG in 50 ML Injection	PSN	5acf0836-93ff-4064-b888-3f560e8a558d	6
2052423	sodium nitroprusside 20 MG in 100 mL Injection	PSN	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876368	sodium nitroprusside 50 MG in 100 ML Injection	PSN	5acf0836-93ff-4064-b888-3f560e8a558d	6
2052424	100 ML sodium nitroprusside 0.2 MG/ML Injection [Nipride]	SBD	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876373	100 ML sodium nitroprusside 0.5 MG/ML Injection [Nipride]	SBD	5acf0836-93ff-4064-b888-3f560e8a558d	6
1999187	50 ML sodium nitroprusside 0.2 MG/ML Injection [Nipride]	SBD	5acf0836-93ff-4064-b888-3f560e8a558d	6
2052423	100 ML sodium nitroprusside 0.2 MG/ML Injection	SCD	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876368	100 ML sodium nitroprusside 0.5 MG/ML Injection	SCD	5acf0836-93ff-4064-b888-3f560e8a558d	6
1999185	50 ML sodium nitroprusside 0.2 MG/ML Injection	SCD	5acf0836-93ff-4064-b888-3f560e8a558d	6
1999187	50 ML Nipride 0.2 MG/ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
2052424	Nipride 0.2 MG/ML per 100 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876373	Nipride 0.5 MG/ML per 100 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
1999187	Nipride 10 MG per 50 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
2052424	Nipride 20 MG per 100 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876373	Nipride 50 MG per 100 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876368	sodium nitroprusside 0.5 MG/ML per 100 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
1999185	sodium nitroprusside 10 MG per 50 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
2052423	sodium nitroprusside 20 MG per 100 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6
1876368	sodium nitroprusside 50 MG per 100 ML Injection	SY	5acf0836-93ff-4064-b888-3f560e8a558d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51754-1018-1	51754101801	50 mL in 1 VIAL	50 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIPRIDE RTU - EXELA PHARMA SCIENCES, LLC	EXELA PHARMA SCIENCES, LLC	2018-07-20	HUMAN PRESCRIPTION DRUG LABEL	6