sodium nitroprusside

Product NDC
14789-012
11-digit product format
147890012
Labeler code
14789
Product ID
14789-012_f3a91a00-5e2f-4bcb-a11f-9458cced50c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium nitroprusside
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Nexus Pharmaceuticals Inc
Application
ANDA207499
Marketing category
ANDA
Marketing start
2017-05-29
Marketing end
0000-00-00
Substance
SODIUM NITROPRUSSIDE
Active strength
25 mg/mL
Pharmacologic classes
Vasodilation [PE], Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct14789-012DDiscontinued by firm2026-08-07
excluded packagepackage14789-01214789-012-02DDiscontinued by firm2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct14789-012IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage14789-01214789-012-02IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…

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
A207499-001SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207499-001AP

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 UTC2026-02A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-253f01610625f2…
2019-09-15 20:21 UTC2019-09A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207499-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2017-05-25cb3db0bc1861…

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 UTC2026-02A207499-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207499-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207499-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207499-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207499-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207499-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207499-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207499-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207499-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207499-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207499-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207499-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207499-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207499-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207499-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207499-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207499-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207499-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207499-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207499-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207499-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207499-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207499-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207499-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207499-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207499-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207499-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207499-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207499-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207499-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207499-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207499-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207499-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207499-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207499-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207499-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207499-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207499-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207499-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207499-001AP1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14789-012-022022-02-03C16284748780-1ba0f9c33-3ce1-a910-e053-dadaa90a0b85Sodium Nitroprusside Injection
14789-012-022021-01-29C16284748780-1ba0f9c33-3ce1-a910-e053-dadaa90a0b85Sodium Nitroprusside Injection

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-012-02ML - Milliliter14789-012612ea87a-726d-43b8-9f81-76e5f0274d9c12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-012SODIUM NITROPRUSSIDE INJECTION [NEXUS PHARMACEUTICALS LLC]9Legacy NDC20241211_870b8428-3e48-40f5-9172-d962adc90dd5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14789-012-02147890012021 VIAL, GLASS in 1 CARTON (14789-012-02) > 2 mL in 1 VIAL, GLASS2017-05-290000-00-00NoNoCurrent