Home NDC 82449-231 FOCINVEZ
Product NDC 82449-231
11-digit product format 824490231
Labeler code 82449
Product ID 82449-231_4e50b25f-abb3-dcb2-e063-6394a90a2517
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FOSAPREPITANT DIMEGLUMINE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Steriscience Specialties Private Limited
Application NDA216686
Marketing category NDA
Marketing start 2024-06-26
Substance FOSAPREPITANT DIMEGLUMINE
Active strength 150 mg/50mL
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 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 N216686-001 FOCINVEZ FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216686-001 11065265 2039-01-11 Drug product 2023-09-13 N216686-001 12042504 2039-01-11 Drug product 2024-08-12
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 2026-08-01 22:54:32 2026-06 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 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 2026-08-01 22:54:32 2026-06 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base FOCINVEZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSAPREPITANT DIMEGLUMINE 150 mg/50mL
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 2664065 Internal RxNorm lookup 2664071 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82449-231-01 FOCINVEZ 1 in 1 CARTON INJECTION 1 5 82449-231-01 FOCINVEZ 50 mL in 1 VIAL, SINGLE-DOSE INJECTION 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82449-231 FOCINVEZ (FOSAPREPITANT DIMEGLUMINE) INJECTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED] 2 Current NDC, 2 package rows 20241205_18a60093-cec8-1b8c-e063-6394a90a8902.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82449-231-01 82449023101 1 VIAL, SINGLE-DOSE in 1 CARTON (82449-231-01) / 50 mL in 1 VIAL, SINGLE-DOSE 2024-06-26 No No Current