Home NDC 83831-144 Avopef
Product NDC 83831-144
11-digit product format 838310144
Labeler code 83831
Product ID 83831-144_76479cd7-c02c-4dae-87d4-b971fabe74f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etoposide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Avyxa Pharma, LLC
Application NDA220200
Marketing category NDA
Marketing start 2026-04-01
Substance ETOPOSIDE
Active strength 100 mg/5mL
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220200-001 AVOPEF ETOPOSIDE 100MG/5ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-13 N220200-002 AVOPEF ETOPOSIDE 500MG/25ML (20MG/ML) SOLUTION / 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 2026-08-18 06:07:40 2026-07 N220200-001 AVOPEF 100MG/5ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220200-002 AVOPEF 500MG/25ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-24 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220200-001 AVOPEF 100MG/5ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-02-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220200-002 AVOPEF 500MG/25ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-06-24 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Avopef
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETOPOSIDE 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6PLQ3CP4P3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310248 Internal RxNorm lookup 2735802 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 83831-144-05 Avopef 5 mL in 1 VIAL INJECTION 5 7 83831-144-05 Avopef 1 in 1 CARTON INJECTION 1 7
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Avopef ETOPOSIDE Avyxa Pharma, LLC acc1e443-ef7b-486f-a638-710a20e81059 2026-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 220200 application number: NDA220200 ndc (product): 83831-144
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83831-144-05 83831014405 1 VIAL in 1 CARTON (83831-144-05) / 5 mL in 1 VIAL 1 vial 2026-04-01 No No Current