Home NDC 83831-153 NAVITRUX
Product NDC 83831-153
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220436-001 NAVITRUX FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2026-06-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N220436-001 NAVITRUX EQ 150MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2026-06-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220436-001 NAVITRUX EQ 150MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2026-06-24 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220436-001 NAVITRUX EQ 150MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2026-06-24 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 NAVITRUX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSAPREPITANT DIMEGLUMINE 150 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D35FM8T64X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731077 Internal RxNorm lookup 2745874 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83831-153-01 83831015301 1 VIAL in 1 CARTON (83831-153-01) / 5 mL in 1 VIAL 1 vial 2026-07-23 No No Current