Home NDC 78670-150 iwilfin
Product NDC 78670-150
11-digit product format 786700150
Labeler code 78670
Product ID 78670-150_5b900700-64d3-4f68-834a-2a71f5216a46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EFLORNITHINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler USWM, LLC
Application NDA215500
Marketing category NDA
Marketing start 2024-01-15
Substance EFLORNITHINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Antiprotozoal [EPC], Decarboxylase Inhibitor [EPC], Decarboxylase Inhibitors [MoA]
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 42 .
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 N215500-001 IWILFIN EFLORNITHINE HYDROCHLORIDE EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215500-001 12582625 2036-02-12 U-4444 2026-04-01
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215500-001 NP 2026-12-13 N215500-001 ODE-462 2030-12-13
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215500-001 IWILFIN EQ 192MG BASE TABLET / ORAL RLD, RS 2023-12-13 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215500-001 12582625 2036-02-12 U-4444 2026-04-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215500-001 12582625 2036-02-12 U-4444 2026-04-01 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base iwilfin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EFLORNITHINE HYDROCHLORIDE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NH22NDW9H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2673199 Internal RxNorm lookup 2673205 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78670-150-01 iwilfin 100 in 1 BOTTLE TABLET 100 7 78670-150-01 iwilfin 1 in 1 CARTON TABLET 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78670-150 IWILFIN (EFLORNITHINE HYDROCHLORIDE) TABLET [USWM, LLC] 5 Current NDC, 2 package rows 20250326_6716d8cc-66e6-4cee-935c-ccb85ed984f5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78670-150-01 78670015001 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE 1 bottle 2024-01-15 No No Current