FDA.reportPublic FDA data

SODIUM NITROPRUSSIDE

Product NDC
42571-265
11-digit product format
425710265
Labeler code
42571
Product ID
42571-265_2e500795-07a7-f0f7-e063-6294a90a4e8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM NITROPRUSSIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Micro Labs Limited
Application
ANDA209352
Marketing category
ANDA
Marketing start
2017-12-30
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
42571-265-752025-02-17C16284748780-12cef2736-a5a3-d83d-e063-dadaa90ab31fSodium Nitroprusside Injection Flip off vial Rx only
42571-265-752025-01-30C16284748780-12cef2736-a5a3-d83d-e063-dadaa90ab31fSodium Nitroprusside Injection Flip off vial Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-265-75SODIUM NITROPRUSSIDE2 mL in 1 VIAL, SINGLE-DOSEINJECTION26
42571-265-75SODIUM NITROPRUSSIDE1 in 1 CARTONINJECTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-265-75ML - Milliliter42571-2650d1fe24b-0c88-471b-9070-76aeca94c6da12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-265SODIUM NITROPRUSSIDE (SODIUM NITROPRUSSIDE) INJECTION [MICRO LABS LIMITED]6Current NDC, Legacy NDC, 2 package rows20250221_5a599880-c133-44ef-a9f2-bd1b681563be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240793sodium nitroprusside 50 MG in 2 ML InjectionPSN5a599880-c133-44ef-a9f2-bd1b681563be6
2407932 ML sodium nitroprusside 25 MG/ML InjectionSCD5a599880-c133-44ef-a9f2-bd1b681563be6
240793sodium nitroprusside 25 MG/ML per 2 ML InjectionSY5a599880-c133-44ef-a9f2-bd1b681563be6
240793sodium nitroprusside 50 MG per 2 ML InjectionSY5a599880-c133-44ef-a9f2-bd1b681563be6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42571-265-75425710265751 VIAL, SINGLE-DOSE in 1 CARTON (42571-265-75) / 2 mL in 1 VIAL, SINGLE-DOSE2017-12-300000-00-00NoNoCurrent