FDA.reportPublic FDA data

Application 018450

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROPRESSSODIUM NITROPRUSSIDEINJECTABLE;INJECTION50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018450-001NITROPRESSSODIUM NITROPRUSSIDE50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018450-001NITROPRESS50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018450-001NITROPRESS50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018450-001NITROPRESS50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018450-001NITROPRESS50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEMicro Labs Limited5a599880-c133-44ef-a9f2-bd1b681563be2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDESomerset Therapeutics, LLC2122b9c1-0af4-493b-82cc-63eee02f987f2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium nitroprussideSODIUM NITROPRUSSIDEMylan Institutional LLC6fbfb86c-da8d-4741-b1e0-7000e2bbad5f2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEDr.Reddy's Laboratories Inc.,a3b83d0e-b8f7-5e90-c363-1edfcd27a33d2025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDECaplin Steriles Limiteda8c5d04b-c6cb-46e6-b90c-e858a0a524062025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEDr.Reddy's Laboratories Inc.,5a689f89-3cbd-f9fa-13cc-26063feb9c832024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEMeitheal Pharmaceuticals Inc.820eadcb-1230-4b17-a652-e69b52b3c12f2024-12-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
sodium nitroprussideSODIUM NITROPRUSSIDEHainan Poly Pharm. Co., Ltd.1f875445-f8e4-b097-e063-6294a90ad5442024-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEArmas Pharmaceuticals Inc.d3f1276a-5944-48e3-8ff1-19995ffb7ef92023-07-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEHainan Poly Pharm. Co., Ltd.72a9b7df-3a2f-4c16-93a9-b645bc0e81432022-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEBE Pharmaceuticals Inc.01841345-bed3-458f-8e99-911fbd2865122021-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEAuroMedics Pharma LLC41e11afb-5fa4-4212-889d-1092dbd0702a2020-12-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
sodium nitroprussideSODIUM NITROPRUSSIDESlate Run Pharmaceuticals, LLC01dfae56-3d9b-448a-84a7-03a54a533eb12020-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium nitroprussideSODIUM NITROPRUSSIDEMylan Institutional LLCa8999285-16b1-473d-8e92-684f581534f62020-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
Sodium nitroprussideSODIUM NITROPRUSSIDEAmneal Pharmaceuticals LLC2fa687a2-10e7-45ae-953a-9d63564c29082019-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE
NIPRIDE RTUSODIUM NITROPRUSSIDEEXELA PHARMA SCIENCES, LLC5acf0836-93ff-4064-b888-3f560e8a558d2018-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.