sodium nitroprusside in 0.9% sodium chloride

Product NDC
70436-207
11-digit product format
704360207
Labeler code
70436
Product ID
70436-207_09c94d69-7bea-2491-e063-6394a90a6438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium nitroprusside in 0.9% sodium chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA215846
Marketing category
ANDA
Marketing start
2022-12-31
Substance
SODIUM NITROPRUSSIDE
Active strength
.5 mg/mL
Pharmacologic classes
Vasodilation [PE], Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215846-001SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-26
A215846-002SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26
A215846-003SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215846-002AP
A215846-003AP

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 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215846-002SODIUM NITROPRUSSIDE20MG/100ML (0.2MG/ML)SOLUTION / INTRAVENOUSAP2022-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215846-003SODIUM NITROPRUSSIDE50MG/100ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215846-001SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML)SOLUTION / INTRAVENOUS2022-08-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215846-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215846-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215846-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215846-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215846-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215846-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215846-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215846-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215846-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215846-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215846-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215846-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215846-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215846-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215846-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215846-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215846-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215846-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215846-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215846-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215846-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215846-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215846-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215846-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215846-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215846-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215846-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215846-003AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215846-002AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215846-003AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215846-002AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215846-003AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215846-002AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215846-003AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215846-002AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215846-003AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215846-002AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215846-003AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215846-002AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215846-003AP1a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
sodium nitroprusside in 0.9% sodium chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM NITROPRUSSIDE.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EAO03PE1TCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1876368Internal RxNorm lookup
1999185Internal RxNorm lookup
2052423Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f02e4ac-5f7c-4003-b9b7-283f489cddb0Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-207-80sodium nitroprusside in 0.9% sodium chloride1 in 1 CARTONINJECTION12
70436-207-80sodium nitroprusside in 0.9% sodium chloride100 mL in 1 VIAL, SINGLE-DOSEINJECTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-207-80ML - Milliliter70436-2075b9cf1e7-9fb7-4ed5-a3f9-62826d85756412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-207SODIUM NITROPRUSSIDE IN 0.9% SODIUM CHLORIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20231114_6f02e4ac-5f7c-4003-b9b7-283f489cddb0.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 nitroprusside in 0.9% sodium chlorideSODIUM NITROPRUSSIDE IN 0.9% SODIUM CHLORIDESlate Run Pharmaceuticals, LLC6f02e4ac-5f7c-4003-b9b7-283f489cddb02023-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215846
application number: ANDA215846
ndc (product): 70436-207
Sodium NitroprussideSODIUM NITROPRUSSIDEHainan Poly Pharm. Co., Ltd.72a9b7df-3a2f-4c16-93a9-b645bc0e81432022-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215846
application number: ANDA215846

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999185sodium nitroprusside 10 MG in 50 ML InjectionPSN6f02e4ac-5f7c-4003-b9b7-283f489cddb02
2052423sodium nitroprusside 20 MG in 100 mL InjectionPSN6f02e4ac-5f7c-4003-b9b7-283f489cddb02
1876368sodium nitroprusside 50 MG in 100 ML InjectionPSN6f02e4ac-5f7c-4003-b9b7-283f489cddb02
2052423100 ML sodium nitroprusside 0.2 MG/ML InjectionSCD6f02e4ac-5f7c-4003-b9b7-283f489cddb02
1876368100 ML sodium nitroprusside 0.5 MG/ML InjectionSCD6f02e4ac-5f7c-4003-b9b7-283f489cddb02
199918550 ML sodium nitroprusside 0.2 MG/ML InjectionSCD6f02e4ac-5f7c-4003-b9b7-283f489cddb02
1876368sodium nitroprusside 0.5 MG/ML per 100 ML InjectionSY6f02e4ac-5f7c-4003-b9b7-283f489cddb02
1999185sodium nitroprusside 10 MG per 50 ML InjectionSY6f02e4ac-5f7c-4003-b9b7-283f489cddb02
2052423sodium nitroprusside 20 MG per 100 ML InjectionSY6f02e4ac-5f7c-4003-b9b7-283f489cddb02
1876368sodium nitroprusside 50 MG per 100 ML InjectionSY6f02e4ac-5f7c-4003-b9b7-283f489cddb02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-207-80704360207801 VIAL, SINGLE-DOSE in 1 CARTON (70436-207-80) / 100 mL in 1 VIAL, SINGLE-DOSE2022-12-31NoNoCurrent