FDA.reportPublic FDA data

Pentamidine Isethionate

Product NDC
13925-515
11-digit product format
139250515
Labeler code
13925
Product ID
13925-515_c83ced5f-9bf2-4367-9146-5b17d0b83371
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pentamidine Isethionate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Seton Pharmaceuticals
Application
ANDA206666
Marketing category
ANDA
Marketing start
2018-04-01
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
Rxcui861601

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
13925-515-102023-06-13C16284748780-1f386c649-b932-0266-e053-dadaa90a7c1aPentamidine Isethionate for injection
13925-515-102023-01-30C16284748780-1f386c649-b932-0266-e053-dadaa90a7c1aPentamidine Isethionate for injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13925-515-10Pentamidine Isethionate300 mg in 1.0 VIALINJECTION, POWDER, LYOPHILIZED,3008
13925-515-10Pentamidine Isethionate10 in 1.0 TRAYINJECTION, POWDER, LYOPHILIZED,108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-515-10EA - Each13925-5156e7fa168-6630-4a21-a515-bbea6280e4e612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-515PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SETON PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20250406_cb8e8155-5505-44d5-9dee-525e2e45b95d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861601pentamidine isethionate 300 MG InjectionPSNcb8e8155-5505-44d5-9dee-525e2e45b95d8
861601pentamidine isethionate 300 MG InjectionSCDcb8e8155-5505-44d5-9dee-525e2e45b95d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13925-515-101392505151010 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIAL10 vial2018-04-010000-00-00NoNoCurrent