Etoposide

Product NDC
71288-175
11-digit product format
712880175
Labeler code
71288
Product ID
71288-175_737a9d5b-1260-408a-a117-b0b3aeba6ad4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etoposide
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA074529
Marketing category
ANDA
Marketing start
2025-02-01
Substance
ETOPOSIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etoposide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOPOSIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6PLQ3CP4P3
Rxcui310248

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
71288-175-05Etoposide1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE13
71288-175-05Etoposide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-175-05ML - Milliliter71288-1753f2064be-dad3-4f4b-b17c-1c8802c38be012025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-175ETOPOSIDE INJECTION, SOLUTION, CONCENTRATE [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250201_50491106-dddd-4efd-bd83-060e7947a244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310248etoposide 20 MG/ML Injectable SolutionPSN50491106-dddd-4efd-bd83-060e7947a2443
310248etoposide 20 MG/ML Injectable SolutionSCD50491106-dddd-4efd-bd83-060e7947a2443
310248etoposide (as etoposide phosphate) 20 MG/ML Injectable SolutionSY50491106-dddd-4efd-bd83-060e7947a2443
310248VP-16 20 MG/ML Injectable SolutionSY50491106-dddd-4efd-bd83-060e7947a2443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-175-05712880175051 VIAL, MULTI-DOSE in 1 CARTON (71288-175-05) / 5 mL in 1 VIAL, MULTI-DOSE2025-02-01NoNoHistorical