FDA.reportPublic FDA data

Pentamidine Isethionate

Product NDC
13925-522
11-digit product format
139250522
Labeler code
13925
Product ID
13925-522_d00d85f7-4ea4-4da2-8c13-7ecc598893e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pentamidine Isethionate
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Seton Pharmaceuticals
Application
ANDA206667
Marketing category
ANDA
Marketing start
2019-10-14
Substance
PENTAMIDINE ISETHIONATE
Active strength
300 mg/300mg
Pharmacologic classes
Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pentamidine Isethionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENTAMIDINE ISETHIONATE300 mg/300mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV2P3K60DA2
Rxcui861597

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7244d69d-a872-4cf7-964d-1d586ba6be0bProduct name220240223
573fdbe8-5a85-49d3-93ae-18a133a8bd58Product name420230103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13925-522-012023-06-13C16284748780-1f386c64a-0cc2-0266-e053-dadaa90a7c1aPentamidine Isethionate for oral inhalation only
13925-522-012023-01-30C16284748780-1f386c64a-0cc2-0266-e053-dadaa90a7c1aPentamidine Isethionate for oral inhalation only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13925-522-01Pentamidine Isethionate300 mg in 1 VIALINHALANT3006
13925-522-01Pentamidine Isethionate1 in 1 CARTONINHALANT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-522-01EA - Each13925-5225c70626f-36ec-4bf8-8b9e-4c6103f3dcbb12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-522PENTAMIDINE ISETHIONATE INHALANT [SETON PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250410_c484f16e-9d97-4416-84a4-8ad8deaf5e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861597pentamidine isethionate 300 MG Inhalation SolutionPSNc484f16e-9d97-4416-84a4-8ad8deaf5e196
861597pentamidine isethionate 50 MG/ML Inhalation SolutionSCDc484f16e-9d97-4416-84a4-8ad8deaf5e196
861597pentamidine isethionate 300 MG Inhalation SolutionSYc484f16e-9d97-4416-84a4-8ad8deaf5e196
861597pentamidine isethionate 300 MG per 6 ML Inhalation SolutionSYc484f16e-9d97-4416-84a4-8ad8deaf5e196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13925-522-01139250522011 VIAL in 1 CARTON (13925-522-01) / 300 mg in 1 VIAL1 vial2019-10-140000-00-00NoNoCurrent