Etoposide

Product NDC
0143-9511
11-digit product format
001439511
Labeler code
0143
Product ID
0143-9511_15cf77cf-4207-463d-b6ef-16163db5afb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etoposide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074290
Marketing category
ANDA
Marketing start
1997-02-01
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
0143-9511-01Etoposide25 mL in 1 VIALINJECTION255
0143-9511-01Etoposide1 in 1 BOX, UNIT-DOSEINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9511-01ML - Milliliter0143-951141d3768a-d3d3-43cd-8322-3f5be4fda67f12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9511ETOPOSIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20230915_6dfedeff-a807-4405-a482-2f7109ad31c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310248etoposide 20 MG/ML Injectable SolutionPSN6dfedeff-a807-4405-a482-2f7109ad31c95
310248etoposide 20 MG/ML Injectable SolutionSCD6dfedeff-a807-4405-a482-2f7109ad31c95
310248etoposide (as etoposide phosphate) 20 MG/ML Injectable SolutionSY6dfedeff-a807-4405-a482-2f7109ad31c95
310248VP-16 20 MG/ML Injectable SolutionSY6dfedeff-a807-4405-a482-2f7109ad31c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9511-01001439511011 VIAL in 1 BOX, UNIT-DOSE (0143-9511-01) / 25 mL in 1 VIAL1 vial2017-10-230000-00-00NoNoCurrent