NebuPent

Product NDC: 63323-877
11-digit product format: 633230877
Labeler code: 63323
Product ID: 63323-877_d673c124-d95f-4751-a11a-a26de8740b3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENTAMIDINE ISETHIONATE
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: Fresenius Kabi USA, LLC
Application: NDA019887
Marketing category: NDA
Marketing start: 2011-02-15
Substance: PENTAMIDINE ISETHIONATE
Active strength: 300 mg/6mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019887-001	NEBUPENT	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15
N019887-002	NEBUPENT	PENTAMIDINE ISETHIONATE	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019887-001	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 3 · 82 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	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019887-001	NEBUPENT	300MG/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1989-06-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019887-002	NEBUPENT	600MG/VIAL	FOR SOLUTION / INHALATION			1996-03-22	`782e0a99824c…`

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	N019887-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019887-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019887-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019887-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019887-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019887-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019887-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019887-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019887-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019887-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019887-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019887-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019887-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019887-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019887-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019887-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019887-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019887-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019887-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019887-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019887-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019887-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019887-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019887-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019887-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019887-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019887-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019887-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019887-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019887-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019887-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019887-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019887-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019887-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019887-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019887-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019887-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019887-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019887-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019887-001	AN	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: NebuPent
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENTAMIDINE ISETHIONATE	300 mg/6mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861597	Internal RxNorm lookup
861599	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
e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-877-15	NebuPent	6 mL in 1 VIAL, SINGLE-DOSE	INHALANT	6		4
63323-877-15	NebuPent	1 in 1 CARTON	INHALANT	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-877-15	EA - Each	63323-877	5e540e8f-5d97-4e66-83fd-f878074b242e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PENTAMIDINE ISETHIONATE	ACTIVE INGREDIENT	V2P3K60DA2	NEBUPENT (PENTAMIDINE ISETHIONATE) INHALANT [APP PHARMACEUTICALS, LLC]	1
PENTAMIDINE	ACTIVE MOIETY	673LC5J4LQ	NEBUPENT (PENTAMIDINE ISETHIONATE) INHALANT [APP PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-877	NEBUPENT (PENTAMIDINE ISETHIONATE) INHALANT [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241020_e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb.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
NebuPent	PENTAMIDINE ISETHIONATE	Fresenius Kabi USA, LLC	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019887 application number: NDA019887 ndc (product): 63323-877

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
861599	NebuPent 300 MG Inhalation Solution	PSN	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	4
861597	pentamidine isethionate 300 MG Inhalation Solution	PSN	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	4
861599	pentamidine isethionate 50 MG/ML Inhalation Solution [NebuPent]	SBD	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	4
861597	pentamidine isethionate 50 MG/ML Inhalation Solution	SCD	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	4
861599	NebuPent 50 MG/ML Inhalation Solution	SY	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	4
861597	pentamidine isethionate 300 MG Inhalation Solution	SY	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	4
861597	pentamidine isethionate 300 MG per 6 ML Inhalation Solution	SY	e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-877-15	63323087715	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE	2011-02-15	0000-00-00	No	No	Current