Home NDC 43068-585 NEREUS
Product NDC 43068-585
11-digit product format 430680585
Labeler code 43068
Product ID 43068-585_03a76717-c241-41e3-8087-dafa6c93eac3
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 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 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 2026-10-15 13:18:30 2026-09 N220152-001 NEREUS 85MG CAPSULE / ORAL RLD, RS 2025-12-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 N220152-001 NEREUS 85MG CAPSULE / ORAL RLD, RS 2025-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220152-001 NEREUS 85MG CAPSULE / ORAL RLD, RS 2025-12-30 caaa826d4ba7…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 2026-10-15 13:18:30 2026-09 N220152-001 10772880 2036-03-04 U-4396 2026-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220152-001 10821099 2036-03-04 U-4396 2026-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220152-001 11324735 2036-03-04 U-4396 2026-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N220152-001 12318375 2036-08-09 U-4396 2026-01-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N220152-001 10772880 2036-03-04 U-4396 2026-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220152-001 10821099 2036-03-04 U-4396 2026-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220152-001 11324735 2036-03-04 U-4396 2026-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220152-001 12318375 2036-08-09 U-4396 2026-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220152-001 10772880 2036-03-04 U-4396 2026-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220152-001 10821099 2036-03-04 U-4396 2026-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220152-001 11324735 2036-03-04 U-4396 2026-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220152-001 12318375 2036-08-09 U-4396 2026-01-28 caaa826d4ba7…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 2026-10-15 13:18:30 2026-09 N220152-001 NCE 2030-12-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 N220152-001 NCE 2030-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220152-001 NCE 2030-12-30 caaa826d4ba7…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…
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 NEREUS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRADIPITANT 85 mg/1
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43068-585-01 43068058501 60 CARTON in 1 BOTTLE (43068-585-01) / 1 CAPSULE in 1 CARTON 60 carton 2026-03-31 No No Current 43068-585-02 43068058502 36 CARTON in 1 BOTTLE (43068-585-02) / 1 CAPSULE in 1 CARTON 36 carton 2026-03-31 No No Current 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 No No Current