IMPAVIDO

Product NDC: 69051-300
11-digit product format: 690510300
Labeler code: 69051
Product ID: 69051-300_5ef65de2-e767-471a-a41b-cbe1fe55cb4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: miltefosine
Dosage form: CAPSULE
Route: ORAL
Labeler: Profounda, Inc.
Application: NDA204684
Marketing category: NDA
Marketing start: 2015-10-29
Marketing end: 0000-00-00
Substance: MILTEFOSINE
Active strength: 50 mg/1
Pharmacologic classes: Antileishmanial [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	69051-300		D	Discontinued by firm		2026-10-05
excluded package	package	69051-300	69051-300-01	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
N204684-001	IMPAVIDO	MILTEFOSINE	50MG	CAPSULE / ORAL		RLD, RS	2014-03-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204684-001	IMPAVIDO	50MG	CAPSULE / ORAL	RLD, RS	2014-03-19	`f41ea6bd6efb…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204684-001	NCE	2019-03-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204684-001	ODE-63	2021-03-19	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N204684-001	ODE-63	2021-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204684-001	ODE-63	2021-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204684-001	ODE-63	2021-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204684-001	ODE-63	2021-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204684-001	ODE-63	2021-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204684-001	NCE	2019-03-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204684-001	ODE-63	2021-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204684-001	NCE	2019-03-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204684-001	ODE-63	2021-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204684-001	NCE	2019-03-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204684-001	ODE-63	2021-03-19	`ea99ee380514…`

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
4a89d3c9-797a-49cb-baae-69b17c58745c	Product name	1	20140721

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-05-08	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014
2023-05-08	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014
2023-01-30	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014
2023-01-30	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014
2021-03-04	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014
2021-03-04	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014
2021-01-29	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014
2021-01-29	These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69051-300-01	IMPAVIDO	2 in 1 CARTON	CAPSULE	2		13
69051-300-01	IMPAVIDO	14 in 1 BLISTER PACK	CAPSULE	14		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69051-300-01	EA - Each	69051-300	c0f00f9d-ed75-47ec-843b-6af57b1a413a	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MILTEFOSINE	ACTIVE INGREDIENT	53EY29W7EC	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
MILTEFOSINE	ACTIVE MOIETY	53EY29W7EC	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69051-300	IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]	12	Legacy NDC, 2 package rows	20250426_bcb387ac-2e90-4f5e-94b2-d3635190678e.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
IMPAVIDO	MILTEFOSINE	Profounda, Inc.	bcb387ac-2e90-4f5e-94b2-d3635190678e	2026-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204684 application number: NDA204684 ndc (product): 69051-300

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
53EY29W7EC	MILTEFOSINE	58066-85-6	MILTEFOSINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1495070	Impavido 50 MG Oral Capsule	PSN	bcb387ac-2e90-4f5e-94b2-d3635190678e	13
1494071	miltefosine 50 MG Oral Capsule	PSN	bcb387ac-2e90-4f5e-94b2-d3635190678e	13
1495070	miltefosine 50 MG Oral Capsule [Impavido]	SBD	bcb387ac-2e90-4f5e-94b2-d3635190678e	13
1494071	miltefosine 50 MG Oral Capsule	SCD	bcb387ac-2e90-4f5e-94b2-d3635190678e	13
1495070	Impavido 50 MG Oral Capsule	SY	bcb387ac-2e90-4f5e-94b2-d3635190678e	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69051-300-01	69051030001	2 BLISTER PACK in 1 CARTON (69051-300-01) > 14 CAPSULE in 1 BLISTER PACK	2 blister pack	2015-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IMPAVIDO	Profounda, Inc. \| Haupt Pharma Amareg GmbH \| Pharma Packaging Solutions, LLC dba TJOAPACK, LLC,	2026-09-30	HUMAN PRESCRIPTION DRUG LABEL	14