Pentamidine Isethionate

Product NDC: 13925-522
11-digit product format: 139250522
Labeler code: 13925
Product ID: 13925-522_d00d85f7-4ea4-4da2-8c13-7ecc598893e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pentamidine Isethionate
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: Seton Pharmaceuticals
Application: ANDA206667
Marketing category: ANDA
Marketing start: 2019-10-14
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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A206667-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION / INHALATION	AN	2019-04-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206667-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION / INHALATION	AN	2019-04-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206667-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206667-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206667-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206667-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206667-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206667-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206667-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206667-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206667-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206667-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206667-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206667-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206667-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206667-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206667-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206667-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206667-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206667-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206667-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206667-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206667-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206667-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206667-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206667-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206667-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206667-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206667-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206667-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206667-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206667-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206667-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206667-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206667-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206667-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206667-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206667-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206667-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206667-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206667-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206667-001	AN	1	`cb3db0bc1861…`

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
861597	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c484f16e-9d97-4416-84a4-8ad8deaf5e19	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7244d69d-a872-4cf7-964d-1d586ba6be0b	Product name	2	20240223
573fdbe8-5a85-49d3-93ae-18a133a8bd58	Product name	4	20230103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13925-522-01	2023-06-13	C162847	48780-1	f386c64a-0cc2-0266-e053-dadaa90a7c1a	Pentamidine Isethionate for oral inhalation only
13925-522-01	2023-01-30	C162847	48780-1	f386c64a-0cc2-0266-e053-dadaa90a7c1a	Pentamidine Isethionate for oral inhalation only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13925-522-01	Pentamidine Isethionate	300 mg in 1 VIAL	INHALANT	300		6
13925-522-01	Pentamidine Isethionate	1 in 1 CARTON	INHALANT	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13925-522-01	EA - Each	13925-522	5c70626f-36ec-4bf8-8b9e-4c6103f3dcbb	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13925-522	PENTAMIDINE ISETHIONATE INHALANT [SETON PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20250410_c484f16e-9d97-4416-84a4-8ad8deaf5e19.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pentamidine Isethionate	PENTAMIDINE ISETHIONATE	PAI Holdings, LLC dba PAI Pharma	4c01d8e9-a25b-4046-8924-53bd9acd560d	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206667 application number: ANDA206667
Pentamidine Isethionate	PENTAMIDINE ISETHIONATE	Seton Pharmaceuticals	c484f16e-9d97-4416-84a4-8ad8deaf5e19	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206667 application number: ANDA206667 ndc (product): 13925-522

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V2P3K60DA2	PENTAMIDINE ISETHIONATE	140-64-7	PENTAMIDINE ISETHIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861597	pentamidine isethionate 300 MG Inhalation Solution	PSN	c484f16e-9d97-4416-84a4-8ad8deaf5e19	6
861597	pentamidine isethionate 50 MG/ML Inhalation Solution	SCD	c484f16e-9d97-4416-84a4-8ad8deaf5e19	6
861597	pentamidine isethionate 300 MG Inhalation Solution	SY	c484f16e-9d97-4416-84a4-8ad8deaf5e19	6
861597	pentamidine isethionate 300 MG per 6 ML Inhalation Solution	SY	c484f16e-9d97-4416-84a4-8ad8deaf5e19	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13925-522-01	13925052201	1 VIAL in 1 CARTON (13925-522-01) / 300 mg in 1 VIAL	1 vial	2019-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pentamidine Isethionate for oral inhalation only	Seton Pharmaceuticals	2025-04-08	HUMAN PRESCRIPTION DRUG LABEL	6