Sodium Nitroprusside

Product NDC: 65145-101
11-digit product format: 651450101
Labeler code: 65145
Product ID: 65145-101_eb59b468-0778-4910-820c-36ca56b935d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Nitroprusside
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Caplin Steriles Limited
Application: ANDA211016
Marketing category: ANDA
Marketing start: 2025-10-29
Substance: SODIUM NITROPRUSSIDE
Active strength: 50 mg/2mL
Pharmacologic classes: Vasodilation [PE], Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65145-101-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65145-101-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65145-101-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65145-101-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65145-101-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65145-101-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65145-101-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65145-101-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
A211016-001	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2019-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211016-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211016-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211016-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211016-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211016-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211016-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211016-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211016-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211016-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211016-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211016-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211016-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211016-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211016-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211016-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211016-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211016-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211016-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211016-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211016-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211016-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211016-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211016-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211016-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211016-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211016-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211016-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211016-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211016-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211016-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211016-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211016-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211016-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211016-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211016-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211016-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211016-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211016-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211016-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM NITROPRUSSIDE	50 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EAO03PE1TC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240793	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
a8c5d04b-c6cb-46e6-b90c-e858a0a52406	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-10-29	a8c5d04b-c6cb-46e6-b90c-e858a0a52406
2025-10-29	a8c5d04b-c6cb-46e6-b90c-e858a0a52406
2025-01-30	a8c5d04b-c6cb-46e6-b90c-e858a0a52406
2025-01-30	a8c5d04b-c6cb-46e6-b90c-e858a0a52406

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65145-101-01	Sodium Nitroprusside	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		4
65145-101-01	Sodium Nitroprusside	1 in 1 CARTON	INJECTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65145-101-01	ML - Milliliter	65145-101	5c396ae7-5ddf-43eb-9d7b-435c2989c4ac	1	2025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65145-101	SODIUM NITROPRUSSIDE INJECTION [CAPLIN STERILES LIMITED]	3	Current NDC, Legacy NDC, 2 package rows	20191210_a8c5d04b-c6cb-46e6-b90c-e858a0a52406.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
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Caplin Steriles Limited	a8c5d04b-c6cb-46e6-b90c-e858a0a52406	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211016 application number: ANDA211016 ndc (product): 65145-101
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Meitheal Pharmaceuticals Inc.	820eadcb-1230-4b17-a652-e69b52b3c12f	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211016 application number: ANDA211016

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
240793	sodium nitroprusside 50 MG in 2 ML Injection	PSN	a8c5d04b-c6cb-46e6-b90c-e858a0a52406	4
240793	2 ML sodium nitroprusside 25 MG/ML Injection	SCD	a8c5d04b-c6cb-46e6-b90c-e858a0a52406	4
240793	sodium nitroprusside 25 MG/ML per 2 ML Injection	SY	a8c5d04b-c6cb-46e6-b90c-e858a0a52406	4
240793	sodium nitroprusside 50 MG per 2 ML Injection	SY	a8c5d04b-c6cb-46e6-b90c-e858a0a52406	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65145-101-01	65145010101	1 VIAL, SINGLE-DOSE in 1 CARTON (65145-101-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2025-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Nitroprusside - Caplin Steriles Limited	Caplin Steriles Limited	2025-10-29	Human Prescription Drug Label	4