Home NDC 0121-1102 Pentamidine Isethionate
Product NDC 0121-1102
11-digit product format 001211102
Labeler code 0121
Product ID 0121-1102_399b48d1-314a-4e14-9790-4cd22da7421c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pentamidine Isethionate
Dosage form INHALANT
Route RESPIRATORY (INHALATION)
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA206667
Marketing category ANDA
Marketing start 2026-06-12
Substance PENTAMIDINE DIISETHIONATE
Active strength 300 mg/300mg
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 43 .
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 A206667-001 PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206667-001 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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206667-001 PENTAMIDINE ISETHIONATE 300MG/VIAL FOR SOLUTION / INHALATION AN 2019-04-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 DIISETHIONATE 300 mg/300mg
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.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0121-1102-55 00121110255 1 VIAL in 1 CARTON (0121-1102-55) / 300 mg in 1 VIAL 1 vial 2026-06-12 No No Current