FDA.reportPublic FDA data

SODIUM NITROPRUSSIDE

Product NDC
72485-105
11-digit product format
724850105
Labeler code
72485
Product ID
72485-105_e2df76e1-9850-4469-a3c0-43d2a8cfeba3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM NITROPRUSSIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA209352
Marketing category
ANDA
Marketing start
2020-03-27
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72485-105-012023-02-16C16284748780-1f386c64a-380d-0266-e053-dadaa90a7c1aSodium Nitroprusside Injection Flip off vial Rx only
72485-105-012023-01-30C16284748780-1f386c64a-380d-0266-e053-dadaa90a7c1aSodium Nitroprusside Injection Flip off vial Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-105-01SODIUM NITROPRUSSIDE2 mL in 1 VIAL, SINGLE-DOSEINJECTION24
72485-105-01SODIUM NITROPRUSSIDE1 in 1 CARTONINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-105-01ML - Milliliter72485-105a05f9dcc-6a5a-4ae1-8028-4028f0e6818312020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-105SODIUM NITROPRUSSIDE (SODIUM NITROPRUSSIDE) INJECTION [ARMAS PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20230801_d3f1276a-5944-48e3-8ff1-19995ffb7ef9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240793sodium nitroprusside 50 MG in 2 ML InjectionPSNd3f1276a-5944-48e3-8ff1-19995ffb7ef94
2407932 ML sodium nitroprusside 25 MG/ML InjectionSCDd3f1276a-5944-48e3-8ff1-19995ffb7ef94
240793sodium nitroprusside 25 MG/ML per 2 ML InjectionSYd3f1276a-5944-48e3-8ff1-19995ffb7ef94
240793sodium nitroprusside 50 MG per 2 ML InjectionSYd3f1276a-5944-48e3-8ff1-19995ffb7ef94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72485-105-01724850105011 VIAL, SINGLE-DOSE in 1 CARTON (72485-105-01) / 2 mL in 1 VIAL, SINGLE-DOSE2020-03-270000-00-00NoNoCurrent