PENTAMIDINE ISETHIONATE

Product NDC: 39822-3050
11-digit product format: 398223050
Labeler code: 39822
Product ID: 39822-3050_dabc42a4-78e0-ec3e-e053-2995a90a1a9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENTAMIDINE ISETHIONATE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: XGen Pharmaceuticals DJB, Inc.
Application: ANDA206982
Marketing category: ANDA
Marketing start: 2022-03-17
Marketing end: 0000-00-00
Substance: PENTAMIDINE ISETHIONATE
Active strength: 300 mg/3mL
Pharmacologic classes: Antiprotozoal [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	39822-3050		D	Discontinued by firm		2026-10-30
excluded package	package	39822-3050	39822-3050-2	D	Discontinued by firm		2026-10-30

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
A206982-001	PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION			2022-03-17

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION		2022-03-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION		2022-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION		2022-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION	AP	2022-03-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206982-001	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE / INJECTION		2022-03-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206982-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206982-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206982-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206982-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206982-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206982-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206982-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206982-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206982-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206982-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206982-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206982-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206982-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206982-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206982-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206982-001	AP	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206982-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206982-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206982-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206982-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206982-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206982-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206982-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206982-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206982-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206982-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206982-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206982-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206982-001	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
39822-3050-2	PENTAMIDINE ISETHIONATE	3 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	3		6
39822-3050-2	PENTAMIDINE ISETHIONATE	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
39822-3050-2	EA - Each	39822-3050	3437a0e9-c1d7-47f2-bf2d-06ca2e0df9bb	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
39822-3050	PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]	6	Legacy NDC, 2 package rows	20240202_860c799c-5199-4f0c-b21b-9910273474d9.zip

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
861601	pentamidine isethionate 300 MG Injection	PSN	860c799c-5199-4f0c-b21b-9910273474d9	6
861601	pentamidine isethionate 300 MG Injection	SCD	860c799c-5199-4f0c-b21b-9910273474d9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
39822-3050-2	39822305002	10 VIAL in 1 CARTON (39822-3050-2) > 3 mL in 1 VIAL	10 vial	2022-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pentamidine isethionate for injection	XGen Pharmaceuticals DJB, Inc.	2024-01-25	HUMAN PRESCRIPTION DRUG LABEL	6