Home NDC 39822-3030 Pentamidine Isethionate
Product NDC 39822-3030
11-digit product format 398223030
Labeler code 39822
Product ID 39822-3030_5d43508a-aac7-adc6-e063-6394a90ae3bf
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206983-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2023-01-20 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pentamidine Isethionate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTAMIDINE ISETHIONATE 300 mg/6mL
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
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