SODIUM NITROPRUSSIDE

Product NDC
72485-305
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72485-305IInactivated by FDA2026-08-11
excluded packagepackage72485-30572485-305-01IInactivated by FDA2026-08-11

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72485-305-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72485-305-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72485-305-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72485-305-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72485-305-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72485-305-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72485-305-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72485-305-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72485-305-01UExcluded because listing certification expired0efc9e666f02…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209352-001SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209352-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAPRS2017-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209352-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-12-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209352-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209352-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209352-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209352-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209352-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209352-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209352-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209352-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209352-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209352-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209352-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209352-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209352-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209352-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209352-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209352-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209352-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209352-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209352-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209352-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209352-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209352-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209352-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209352-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209352-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209352-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209352-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209352-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209352-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209352-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209352-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209352-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209352-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209352-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209352-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209352-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209352-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209352-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209352-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209352-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baa2d9bb-fc02-4e7a-afa2-38f3bd0d9f47Product name220230501
374f859f-b175-4ec0-a0a3-35bda0517e25Product name920200522

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-305-01SODIUM NITROPRUSSIDE2 mL in 1 VIAL, SINGLE-DOSEINJECTION22
72485-305-01SODIUM NITROPRUSSIDE1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-305-01ML - Milliliter72485-305b008866e-b351-4db9-8ce3-0d81bb3c643712021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-305SODIUM NITROPRUSSIDE (SODIUM NITROPRUSSIDE) INJECTION [ARMAS PHARMACEUTICALS INC.]2Legacy NDC, 2 package rows20230217_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEMicro Labs Limited5a599880-c133-44ef-a9f2-bd1b681563be2025-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209352
application number: ANDA209352
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEArmas Pharmaceuticals Inc.d3f1276a-5944-48e3-8ff1-19995ffb7ef92023-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209352
application number: ANDA209352

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240793sodium nitroprusside 50 MG in 2 ML InjectionPSN7581e618-d03a-4968-ad6a-c15e246b41692
2407932 ML sodium nitroprusside 25 MG/ML InjectionSCD7581e618-d03a-4968-ad6a-c15e246b41692
240793sodium nitroprusside 25 MG/ML per 2 ML InjectionSY7581e618-d03a-4968-ad6a-c15e246b41692
240793sodium nitroprusside 50 MG per 2 ML InjectionSY7581e618-d03a-4968-ad6a-c15e246b41692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72485-305-01724850305011 VIAL, SINGLE-DOSE in 1 CARTON (72485-305-01) > 2 mL in 1 VIAL, SINGLE-DOSE2021-09-150000-00-00NoNoCurrent