Home NDC 71863-135 IMPAVIDO
Product NDC 71863-135
11-digit product format 718630135
Labeler code 71863
Product ID 71863-135_57c515c8-f4b0-b876-e063-6394a90af0cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Miltefosine
Dosage form CAPSULE
Route ORAL
Labeler Eton Pharmaceuticals, Inc.
Application NDA204684
Marketing category NDA
Marketing start 2026-09-26
Substance MILTEFOSINE
Active strength 50 mg/1
Pharmacologic classes Antileishmanial [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Product TE source text 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# 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MILTEFOSINE 50 mg/1
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71863-135-28 71863013528 2 BLISTER PACK in 1 CARTON (71863-135-28) / 14 CAPSULE in 1 BLISTER PACK 2 blister pack 2026-09-26 No No Current