FDA.reportPublic FDA data

Sodium Nitroprusside

Product NDC
43598-587
11-digit product format
435980587
Labeler code
43598
Product ID
43598-587_367c01f3-9128-7427-1da8-862b4a9b650c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Nitroprusside
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Dr.Reddy's Laboratories Inc.,
Application
ANDA210114
Marketing category
ANDA
Marketing start
2019-12-17
Substance
SODIUM NITROPRUSSIDE
Active strength
50 mg/2mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM NITROPRUSSIDE50 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEAO03PE1TC
Rxcui240793

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
43598-587-23Sodium Nitroprusside2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION24
43598-587-23Sodium Nitroprusside1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-587-23ML - Milliliter43598-5878b8e5749-582e-4a4f-b558-7de0925317c912020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-587SODIUM NITROPRUSSIDE INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC.,]4Current NDC, Legacy NDC, 2 package rows20241222_5a689f89-3cbd-f9fa-13cc-26063feb9c83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240793sodium nitroprusside 50 MG in 2 ML InjectionPSN5a689f89-3cbd-f9fa-13cc-26063feb9c834
2407932 ML sodium nitroprusside 25 MG/ML InjectionSCD5a689f89-3cbd-f9fa-13cc-26063feb9c834
240793sodium nitroprusside 25 MG/ML per 2 ML InjectionSY5a689f89-3cbd-f9fa-13cc-26063feb9c834
240793sodium nitroprusside 50 MG per 2 ML InjectionSY5a689f89-3cbd-f9fa-13cc-26063feb9c834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-587-23435980587231 VIAL, SINGLE-DOSE in 1 CARTON (43598-587-23) / 2 mL in 1 VIAL, SINGLE-DOSE2019-12-170000-00-00NoNoCurrent