FDA.reportPublic FDA data

NAVITRUX

Product NDC
83831-153
Requested package NDC
83831-153-01
11-digit product format
838310153
Labeler code
83831
Product ID
83831-153_bc79f63b-8a05-41b5-a349-f71f1313e791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
AVYXA Pharma, LLC
Application
NDA220436
Marketing category
NDA
Marketing start
2026-07-23
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 mg/5mL
Pharmacologic classes
Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220436-001NAVITRUXFOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2026-06-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220436-001NAVITRUXEQ 150MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2026-06-2484e616aacf4f…
2026-08-18 06:07:402026-07N220436-001NAVITRUXEQ 150MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2026-06-24caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220436-001NAVITRUXEQ 150MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2026-06-24a50c72e98297…

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
NAVITRUX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAPREPITANT DIMEGLUMINE150 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D35FM8T64XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1731077Internal RxNorm lookup
2745874Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a41b7c3a-1376-43a7-b5b9-6ba2eba1e169Available on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAVITRUXFOSAPREPITANTAVYXA Pharma, LLCa41b7c3a-1376-43a7-b5b9-6ba2eba1e1692026-07-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 220436
application number: NDA220436
ndc (package): 83831-153-01
ndc (product): 83831-153
ndc11 (package): 83831015301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83831-153-01838310153011 VIAL in 1 CARTON (83831-153-01) / 5 mL in 1 VIAL1 vial2026-07-23NoNoCurrent