Home NDC 43068-585-03 NEREUS
Product NDC 43068-585
Requested package NDC 43068-585-03
11-digit product format 430680585
Labeler code 43068
Product ID 43068-585_ca9e3433-499f-4519-bc3a-2d78302ee6a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRADIPITANT
Dosage form CAPSULE
Route ORAL
Labeler Vanda Pharmaceuticals Inc.
Application NDA220152
Marketing category NDA
Marketing start 2026-03-31
Substance TRADIPITANT
Active strength 85 mg/1
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 1 .
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 N220152-001 NEREUS TRADIPITANT 85MG CAPSULE / ORAL RLD, RS 2025-12-30
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220152-001 10772880 2036-03-04 U-4396 2026-01-28 N220152-001 10821099 2036-03-04 U-4396 2026-01-28 N220152-001 11324735 2036-03-04 U-4396 2026-01-28 N220152-001 12318375 2036-08-09 U-4396 2026-01-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220152-001 NCE 2030-12-30
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 2026-02-19 14:30 UTC 2026-02 N220152-001 NEREUS 85MG CAPSULE / ORAL RLD, RS 2025-12-30 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220152-001 NEREUS 85MG CAPSULE / ORAL RLD, RS 2025-12-30 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 2026-02-19 14:30 UTC 2026-02 N220152-001 10772880 2036-03-04 U-4396 2026-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N220152-001 10821099 2036-03-04 U-4396 2026-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N220152-001 11324735 2036-03-04 U-4396 2026-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N220152-001 12318375 2036-08-09 U-4396 2026-01-28 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220152-001 10772880 2036-03-04 U-4396 2026-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220152-001 10821099 2036-03-04 U-4396 2026-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220152-001 11324735 2036-03-04 U-4396 2026-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220152-001 12318375 2036-08-09 U-4396 2026-01-28 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N220152-001 NCE 2030-12-30 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220152-001 NCE 2030-12-30 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base NEREUS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRADIPITANT 85 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NY0COC51FI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2739511 Internal RxNorm lookup 2739517 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 43068-585-01 NEREUS 60 in 1 BOTTLE CAPSULE 60 3 43068-585-01 NEREUS 1 in 1 CARTON CAPSULE 1 3 43068-585-02 NEREUS 1 in 1 CARTON CAPSULE 1 3 43068-585-02 NEREUS 36 in 1 BOTTLE CAPSULE 36 3
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 Status 43068-585-03 43068058503 2 BLISTER PACK in 1 KIT (43068-585-03) / 1 CAPSULE in 1 BLISTER PACK 2 blister pack 2026-03-31 0 Current