Home NDC 69051-300 IMPAVIDO
Product NDC 69051-300
11-digit product format 690510300
Labeler code 69051
Product ID 69051-300_5d5727be-1d76-8f8f-e063-6294a90aa8be
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 2028-01-31
Substance MILTEFOSINE
Active strength 50 mg/1
Pharmacologic classes Antileishmanial [EPC]
NDC exclude flag No
Current FDA listing Yes 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 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 · 44 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 2026-10-15 13:18:30 2026-09 N204684-001 IMPAVIDO 50MG CAPSULE / ORAL RLD, RS 2014-03-19 c2088c7a36db…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…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base IMPAVIDO Active Ingredients# Ingredient, Strength table Ingredient Strength MILTEFOSINE 50 mg/1
DailyMed Product Concepts# 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 2023-05-08 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 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 2021-03-04 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 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 Current NDC, Legacy NDC, 2 package rows 20250426_bcb387ac-2e90-4f5e-94b2-d3635190678e.zip
DailyMed RxNorm Mappings# 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 2028-01-31 No No Current