FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiEAO03PE1TC
Rxcui1876368, 1999185, 2052423

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

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-DOSE2022-12-31NoNoHistorical