SODIUM NITROPRUSSIDE

Product NDC: 72485-305
Requested package NDC: 72485-305-01
11-digit product format: 724850305
Labeler code: 72485
Product ID: 72485-305_eec7048d-b6db-4fc5-8aed-d93f037780d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM NITROPRUSSIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA209352
Marketing category: ANDA
Marketing start: 2021-09-15
Marketing end: 0000-00-00
Substance: SODIUM NITROPRUSSIDE
Active strength: 50 mg/2mL
Pharmacologic classes: Vasodilation [PE],Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72485-305	72485-305-01	I	Inactivated by FDA		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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	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
A209352-001	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209352-001	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.

Product history page 1 of 2 · 41 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	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS	2017-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209352-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2017-12-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A209352-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209352-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209352-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209352-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209352-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209352-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209352-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209352-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209352-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209352-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209352-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209352-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209352-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209352-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209352-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209352-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209352-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209352-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209352-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209352-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209352-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209352-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209352-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209352-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209352-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209352-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209352-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209352-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209352-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209352-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209352-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209352-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209352-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209352-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209352-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209352-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209352-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209352-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209352-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209352-001	AP	1	`cb3db0bc1861…`

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72485-305-01	2025-01-30	C162847	48780-1	f386c649-ef4c-0266-e053-dadaa90a7c1a	Sodium Nitroprusside Injection Flip off Vial novaplus TM Rx only
72485-305-01	2023-02-16	C162847	48780-1	f386c649-ef4c-0266-e053-dadaa90a7c1a	Sodium Nitroprusside Injection Flip off Vial novaplus TM Rx only
72485-305-01	2023-01-30	C162847	48780-1	f386c649-ef4c-0266-e053-dadaa90a7c1a	Sodium Nitroprusside Injection Flip off Vial novaplus TM Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72485-305-01	SODIUM NITROPRUSSIDE	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		2
72485-305-01	SODIUM NITROPRUSSIDE	1 in 1 CARTON	INJECTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72485-305-01	ML - Milliliter	72485-305	b008866e-b351-4db9-8ce3-0d81bb3c6437	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-305	SODIUM NITROPRUSSIDE (SODIUM NITROPRUSSIDE) INJECTION [ARMAS PHARMACEUTICALS INC.]	2	Legacy NDC, 2 package rows	20230217_7581e618-d03a-4968-ad6a-c15e246b4169.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	Micro Labs Limited	5a599880-c133-44ef-a9f2-bd1b681563be	2025-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209352 application number: ANDA209352
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	Armas Pharmaceuticals Inc.	d3f1276a-5944-48e3-8ff1-19995ffb7ef9	2023-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209352 application number: ANDA209352

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	7581e618-d03a-4968-ad6a-c15e246b4169	2
240793	2 ML sodium nitroprusside 25 MG/ML Injection	SCD	7581e618-d03a-4968-ad6a-c15e246b4169	2
240793	sodium nitroprusside 25 MG/ML per 2 ML Injection	SY	7581e618-d03a-4968-ad6a-c15e246b4169	2
240793	sodium nitroprusside 50 MG per 2 ML Injection	SY	7581e618-d03a-4968-ad6a-c15e246b4169	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72485-305-01	72485030501	1 VIAL, SINGLE-DOSE in 1 CARTON (72485-305-01) > 2 mL in 1 VIAL, SINGLE-DOSE	2021-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Nitroprusside Injection Flip off Vial novaplus TM Rx only	Armas Pharmaceuticals Inc.	2023-02-16	HUMAN PRESCRIPTION DRUG LABEL	2