FDA.reportPublic FDA data

Avopef

Product NDC
83831-144
11-digit product format
838310144
Labeler code
83831
Product ID
83831-144_3421b13e-3145-4ca9-9fdb-2c1ff2b14e51
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220200-001AVOPEFETOPOSIDE100MG/5ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-13
N220200-002AVOPEFETOPOSIDE500MG/25ML (20MG/ML)SOLUTION / 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 22:38:342026-08N220200-001AVOPEF100MG/5ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-1384e616aacf4f…
2026-09-14 22:38:342026-08N220200-002AVOPEF500MG/25ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-2484e616aacf4f…
2026-08-18 06:07:402026-07N220200-001AVOPEF100MG/5ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07N220200-002AVOPEF500MG/25ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-06-24caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220200-001AVOPEF100MG/5ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220200-002AVOPEF500MG/25ML (20MG/ML)SOLUTION / 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
Avopef
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOPOSIDE100 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ab98334-79be-46be-f4f5-d4a6cc04219eProduct name320180118
4896aaa2-df52-a28b-a484-cf928e9408caProduct name120140508
e9a73b62-e9c6-118b-a3be-022705d13855Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83831-144-05Avopef5 mL in 1 VIALINJECTION57
83831-144-05Avopef1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83831-144-05ML - Milliliter83831-144ebad1ad5-4d24-4e1a-8d22-615e558f4b4612026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2735802AVOPEF 20 MG/ML Injectable SolutionPSNacc1e443-ef7b-486f-a638-710a20e810597
310248etoposide 20 MG/ML Injectable SolutionPSNacc1e443-ef7b-486f-a638-710a20e810597
2735802etoposide 20 MG/ML Injectable Solution [Avopef]SBDacc1e443-ef7b-486f-a638-710a20e810597
310248etoposide 20 MG/ML Injectable SolutionSCDacc1e443-ef7b-486f-a638-710a20e810597
2735802Avopef 20 MG/ML Injectable SolutionSYacc1e443-ef7b-486f-a638-710a20e810597
310248etoposide (as etoposide phosphate) 20 MG/ML Injectable SolutionSYacc1e443-ef7b-486f-a638-710a20e810597
310248VP-16 20 MG/ML Injectable SolutionSYacc1e443-ef7b-486f-a638-710a20e810597
2735802VP-16 20 MG/ML Injectable Solution [Avopef]SYacc1e443-ef7b-486f-a638-710a20e810597

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83831-144-05838310144051 VIAL in 1 CARTON (83831-144-05) / 5 mL in 1 VIAL1 vial2026-04-01NoNoCurrent