FDA.reportPublic FDA data

NIPRIDE RTU

Product NDC
51754-1018
11-digit product format
517541018
Labeler code
51754
Product ID
51754-1018_ed0040fb-c481-4477-8712-00fa6350cd70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Nitroprusside
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
EXELA PHARMA SCIENCES, LLC
Application
NDA209387
Marketing category
NDA
Marketing start
2018-02-09
Marketing end
2019-08-30
Substance
SODIUM NITROPRUSSIDE
Active strength
0 mg/mL
Pharmacologic classes
Vasodilation [PE],Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
51754-1018-1NIPRIDE RTU50 mL in 1 VIALINJECTION, SOLUTION506
51754-1018-1NIPRIDE RTU1 in 1 VIALINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-1018NIPRIDE RTU (SODIUM NITROPRUSSIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]6Legacy NDC, 2 package rows20190607_5acf0836-93ff-4064-b888-3f560e8a558d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999187NIPRIDE RTU 10 MG in 50 ML InjectionPSN5acf0836-93ff-4064-b888-3f560e8a558d6
2052424NIPRIDE RTU 20 MG in 100 mL InjectionPSN5acf0836-93ff-4064-b888-3f560e8a558d6
1876373NIPRIDE RTU 50 MG in 100 ML InjectionPSN5acf0836-93ff-4064-b888-3f560e8a558d6
1999185sodium nitroprusside 10 MG in 50 ML InjectionPSN5acf0836-93ff-4064-b888-3f560e8a558d6
2052423sodium nitroprusside 20 MG in 100 mL InjectionPSN5acf0836-93ff-4064-b888-3f560e8a558d6
1876368sodium nitroprusside 50 MG in 100 ML InjectionPSN5acf0836-93ff-4064-b888-3f560e8a558d6
2052424100 ML sodium nitroprusside 0.2 MG/ML Injection [Nipride]SBD5acf0836-93ff-4064-b888-3f560e8a558d6
1876373100 ML sodium nitroprusside 0.5 MG/ML Injection [Nipride]SBD5acf0836-93ff-4064-b888-3f560e8a558d6
199918750 ML sodium nitroprusside 0.2 MG/ML Injection [Nipride]SBD5acf0836-93ff-4064-b888-3f560e8a558d6
2052423100 ML sodium nitroprusside 0.2 MG/ML InjectionSCD5acf0836-93ff-4064-b888-3f560e8a558d6
1876368100 ML sodium nitroprusside 0.5 MG/ML InjectionSCD5acf0836-93ff-4064-b888-3f560e8a558d6
199918550 ML sodium nitroprusside 0.2 MG/ML InjectionSCD5acf0836-93ff-4064-b888-3f560e8a558d6
199918750 ML Nipride 0.2 MG/ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
2052424Nipride 0.2 MG/ML per 100 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
1876373Nipride 0.5 MG/ML per 100 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
1999187Nipride 10 MG per 50 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
2052424Nipride 20 MG per 100 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
1876373Nipride 50 MG per 100 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
1876368sodium nitroprusside 0.5 MG/ML per 100 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
1999185sodium nitroprusside 10 MG per 50 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
2052423sodium nitroprusside 20 MG per 100 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6
1876368sodium nitroprusside 50 MG per 100 ML InjectionSY5acf0836-93ff-4064-b888-3f560e8a558d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51754-1018-15175410180150 mL in 1 VIAL50 mlHistorical