Home NDC 13925-515 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 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 A206666-001 PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206666-001 AP
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206666-001 PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP 2017-09-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/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 861601 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13925-515-10 Pentamidine Isethionate 300 mg in 1.0 VIAL INJECTION, POWDER, LYOPHILIZED, 300 8 13925-515-10 Pentamidine Isethionate 10 in 1.0 TRAY INJECTION, POWDER, LYOPHILIZED, 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13925-515 PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SETON PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 2 package rows 20250406_cb8e8155-5505-44d5-9dee-525e2e45b95d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13925-515-10 13925051510 10 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIAL 10 vial 2018-04-01 0000-00-00 No No Current