FDA.reportPublic FDA data

Pentamidine Isethionate

Product NDC
39822-3030
11-digit product format
398223030
Labeler code
39822
Product ID
39822-3030_13f0833c-208d-be41-e063-6294a90a627b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PENTAMIDINE ISETHIONATE
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA206983
Marketing category
ANDA
Marketing start
2023-04-04
Substance
PENTAMIDINE ISETHIONATE
Active strength
300 mg/6mL
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/6mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-3030-1Pentamidine Isethionate6 mL in 1 VIAL, SINGLE-DOSEINHALANT66
39822-3030-2Pentamidine Isethionate1 in 1 CARTONINHALANT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-3030-1EA - Each39822-303066f4b4e2-7c76-4e82-851e-b887e19e234612023-07-06
39822-3030-2EA - Each39822-303026e07bd3-dddf-43aa-aae5-f51bc1ff224912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-3030PENTAMIDINE ISETHIONATE INHALANT [XGEN PHARMACEUTICALS DJB, INC.]6Current NDC, 2 package rows20240320_490a231d-bb24-403d-9733-1a562ecd5917.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861597pentamidine isethionate 300 MG Inhalation SolutionPSN490a231d-bb24-403d-9733-1a562ecd59176
861597pentamidine isethionate 50 MG/ML Inhalation SolutionSCD490a231d-bb24-403d-9733-1a562ecd59176
861597pentamidine isethionate 300 MG Inhalation SolutionSY490a231d-bb24-403d-9733-1a562ecd59176
861597pentamidine isethionate 300 MG per 6 ML Inhalation SolutionSY490a231d-bb24-403d-9733-1a562ecd59176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39822-3030-1398223030016 mL in 1 VIAL, SINGLE-DOSE6 mlHistorical
39822-3030-2398223030021 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1) 2023-04-04NoNoHistorical