FDA.reportPublic FDA data

Sodium Nitroprusside

Product NDC
14335-132
11-digit product format
143350132
Labeler code
14335
Product ID
14335-132_e826d769-c243-f0ac-e053-2995a90afcff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Nitroprusside
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA215846
Marketing category
ANDA
Marketing start
2022-12-31
Substance
SODIUM NITROPRUSSIDE
Active strength
.2 mg/mL
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 NITROPRUSSIDE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEAO03PE1TC
Rxcui1876368, 1999185, 2052423

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
14335-132-01Sodium Nitroprusside1 in 1 CARTONINJECTION, SOLUTION11
14335-132-01Sodium Nitroprusside50 mL in 1 VIALINJECTION, SOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-132SODIUM NITROPRUSSIDE INJECTION, SOLUTION [HAINAN POLY PHARM. CO., LTD.]1Current NDC, Legacy NDC, 2 package rows20221231_72a9b7df-3a2f-4c16-93a9-b645bc0e8143.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999185sodium nitroprusside 10 MG in 50 ML InjectionPSN72a9b7df-3a2f-4c16-93a9-b645bc0e81431
2052423sodium nitroprusside 20 MG in 100 mL InjectionPSN72a9b7df-3a2f-4c16-93a9-b645bc0e81431
1876368sodium nitroprusside 50 MG in 100 ML InjectionPSN72a9b7df-3a2f-4c16-93a9-b645bc0e81431
2052423100 ML sodium nitroprusside 0.2 MG/ML InjectionSCD72a9b7df-3a2f-4c16-93a9-b645bc0e81431
1876368100 ML sodium nitroprusside 0.5 MG/ML InjectionSCD72a9b7df-3a2f-4c16-93a9-b645bc0e81431
199918550 ML sodium nitroprusside 0.2 MG/ML InjectionSCD72a9b7df-3a2f-4c16-93a9-b645bc0e81431
1876368sodium nitroprusside 0.5 MG/ML per 100 ML InjectionSY72a9b7df-3a2f-4c16-93a9-b645bc0e81431
1999185sodium nitroprusside 10 MG per 50 ML InjectionSY72a9b7df-3a2f-4c16-93a9-b645bc0e81431
2052423sodium nitroprusside 20 MG per 100 ML InjectionSY72a9b7df-3a2f-4c16-93a9-b645bc0e81431
1876368sodium nitroprusside 50 MG per 100 ML InjectionSY72a9b7df-3a2f-4c16-93a9-b645bc0e81431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14335-132-01143350132011 VIAL in 1 CARTON (14335-132-01) / 50 mL in 1 VIAL1 vial2022-12-310000-00-00NoNoCurrent