NEREUS

Product NDC
43068-585
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

Additional Listing Data#

Finished product
Yes
Brand name base
NEREUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRADIPITANT85 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNY0COC51FI
Rxcui2739511, 2739517

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43068-585-01NEREUS60 in 1 BOTTLECAPSULE603
43068-585-01NEREUS1 in 1 CARTONCAPSULE13
43068-585-02NEREUS1 in 1 CARTONCAPSULE13
43068-585-02NEREUS36 in 1 BOTTLECAPSULE363

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43068-585-01EA - Each43068-58588af9f64-6448-4c7b-8c33-5ca001fefa5f12026-04-20
43068-585-02EA - Each43068-5855c95d23b-d24a-41a4-9fdc-7738e7faab3912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739517NEREUS 85 MG Oral CapsulePSN1a021ebd-16ac-4354-b4b2-1c3950c091e53
2739511tradipitant 85 MG Oral CapsulePSN1a021ebd-16ac-4354-b4b2-1c3950c091e53
2739517tradipitant 85 MG Oral Capsule [Nereus]SBD1a021ebd-16ac-4354-b4b2-1c3950c091e53
2739511tradipitant 85 MG Oral CapsuleSCD1a021ebd-16ac-4354-b4b2-1c3950c091e53
2739517Nereus 85 MG Oral CapsuleSY1a021ebd-16ac-4354-b4b2-1c3950c091e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43068-585-014306805850160 CARTON in 1 BOTTLE (43068-585-01) / 1 CAPSULE in 1 CARTON60 carton2026-03-31NoNoCurrent
43068-585-024306805850236 CARTON in 1 BOTTLE (43068-585-02) / 1 CAPSULE in 1 CARTON36 carton2026-03-31NoNoCurrent