Etoposide

Product NDC
0378-3266
11-digit product format
003783266
Labeler code
0378
Product ID
0378-3266_a591eea6-af04-4207-b0f7-61fbada4719c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etoposide
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075635
Marketing category
ANDA
Marketing start
2001-10-22
Substance
ETOPOSIDE
Active strength
50 mg/1
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
ETOPOSIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6PLQ3CP4P3
Rxcui197687

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
0378-3266-94Etoposide20 in 1 CARTONCAPSULE209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3266-94EA - Each0378-32665d1182dc-cf02-4a9e-a825-52ddc5f553ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETOPOSIDEACTIVE INGREDIENT6PLQ3CP4P3ETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
ETOPOSIDEACTIVE MOIETY6PLQ3CP4P3ETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3266ETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 1 package rows20181019_508a418e-985f-4208-9324-2230655bb5c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197687etoposide 50 MG Oral CapsulePSN508a418e-985f-4208-9324-2230655bb5c29
197687etoposide 50 MG Oral CapsuleSCD508a418e-985f-4208-9324-2230655bb5c29
197687VP-16 50 MG Oral CapsuleSY508a418e-985f-4208-9324-2230655bb5c29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3266-940037832669420 CAPSULE in 1 CARTON (0378-3266-94) 20 capsule2001-10-220000-00-00NoNoCurrent