Home NDC 39822-3030 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206983-001 PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206983-001 AN
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pentamidine Isethionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTAMIDINE ISETHIONATE 300 mg/6mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V2P3K60DA2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861597 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 39822-3030-1 Pentamidine Isethionate 6 mL in 1 VIAL, SINGLE-DOSE INHALANT 6 6 39822-3030-2 Pentamidine Isethionate 1 in 1 CARTON INHALANT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-3030 PENTAMIDINE ISETHIONATE INHALANT [XGEN PHARMACEUTICALS DJB, INC.] 6 Current NDC, 2 package rows 20240320_490a231d-bb24-403d-9733-1a562ecd5917.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 39822-3030-1 39822303001 6 mL in 1 VIAL, SINGLE-DOSE 6 ml Historical 39822-3030-2 39822303002 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1) 2023-04-04 No No Current