PENTAMIDINE ISETHIONATE

Product NDC: 39822-3050
Requested package NDC: 39822-3050-2
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	39822-3050	39822-3050-2	D	Discontinued by firm		2026-10-05

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
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
2026-09-14 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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	XGen Pharmaceuticals DJB, Inc.	860c799c-5199-4f0c-b21b-9910273474d9	2024-01-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206982 application number: ANDA206982 ndc (package): 39822-3050-2 ndc (product): 39822-3050 ndc11 (package): 39822305002

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