Etoposide

Product NDC
0143-9376
11-digit product format
001439376
Labeler code
0143
Product ID
0143-9376_47d0c5ee-081e-44f7-9593-9888ae033165
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etoposide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074290
Marketing category
ANDA
Marketing start
1996-05-01
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
0143-9376-01Etoposide5 mL in 1 VIALINJECTION52
0143-9376-01Etoposide1 in 1 BOX, UNIT-DOSEINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9376-01ML - Milliliter0143-9376ad4e700d-557a-433b-85d6-5f11566d28ea12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9376ETOPOSIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 2 package rows20240906_e0cd61b9-2375-4e3d-a610-d87dad962468.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310248etoposide 20 MG/ML Injectable SolutionPSNe0cd61b9-2375-4e3d-a610-d87dad9624682
310248etoposide 20 MG/ML Injectable SolutionSCDe0cd61b9-2375-4e3d-a610-d87dad9624682
310248etoposide (as etoposide phosphate) 20 MG/ML Injectable SolutionSYe0cd61b9-2375-4e3d-a610-d87dad9624682
310248VP-16 20 MG/ML Injectable SolutionSYe0cd61b9-2375-4e3d-a610-d87dad9624682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9376-01001439376011 VIAL in 1 BOX, UNIT-DOSE (0143-9376-01) / 5 mL in 1 VIAL1 vial2019-10-010000-00-00NoNoCurrent