Sodium Nitroprusside

Product NDC
65145-101
11-digit product format
651450101
Labeler code
65145
Product ID
65145-101_eb59b468-0778-4910-820c-36ca56b935d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Nitroprusside
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA211016
Marketing category
ANDA
Marketing start
2025-10-29
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-101-01Sodium Nitroprusside2 mL in 1 VIAL, SINGLE-DOSEINJECTION24
65145-101-01Sodium Nitroprusside1 in 1 CARTONINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-101-01ML - Milliliter65145-1015c396ae7-5ddf-43eb-9d7b-435c2989c4ac12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-101SODIUM NITROPRUSSIDE INJECTION [CAPLIN STERILES LIMITED]3Current NDC, Legacy NDC, 2 package rows20191210_a8c5d04b-c6cb-46e6-b90c-e858a0a52406.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240793sodium nitroprusside 50 MG in 2 ML InjectionPSNa8c5d04b-c6cb-46e6-b90c-e858a0a524064
2407932 ML sodium nitroprusside 25 MG/ML InjectionSCDa8c5d04b-c6cb-46e6-b90c-e858a0a524064
240793sodium nitroprusside 25 MG/ML per 2 ML InjectionSYa8c5d04b-c6cb-46e6-b90c-e858a0a524064
240793sodium nitroprusside 50 MG per 2 ML InjectionSYa8c5d04b-c6cb-46e6-b90c-e858a0a524064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65145-101-01651450101011 VIAL, SINGLE-DOSE in 1 CARTON (65145-101-01) / 2 mL in 1 VIAL, SINGLE-DOSE2025-10-290000-00-00NoNoCurrent