FDA.reportPublic FDA data

Etoposide

Product NDC
63323-104
11-digit product format
633230104
Labeler code
63323
Product ID
63323-104_d672a555-bb0e-4a82-ac5e-5c9393b59c28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETOPOSIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA074983
Marketing category
ANDA
Marketing start
2001-07-18
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
63323-104-01Etoposide1 in 1 BOXINJECTION, SOLUTION16
63323-104-01Etoposide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION56
63323-104-05Etoposide10 in 1 CARTONINJECTION, SOLUTION106
63323-104-06Etoposide1 in 1 CARTONINJECTION, SOLUTION16
63323-104-06Etoposide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION56
63323-104-25Etoposide25 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION256
63323-104-25Etoposide1 in 1 CARTONINJECTION, SOLUTION16
63323-104-50Etoposide1 in 1 CARTONINJECTION, SOLUTION16
63323-104-50Etoposide50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-104-01ML - Milliliter63323-10481083c41-85e6-450e-bb64-3e96b6a74a3c12020-03-10
63323-104-05ML - Milliliter63323-104737e6d1b-70ff-458e-bd0e-d549b8c9c14c12013-02-13
63323-104-06ML - Milliliter63323-104306edf37-1ce9-46fb-9318-e4a089f7a40712024-07-12
63323-104-25ML - Milliliter63323-10476b46cb3-d8a7-478c-8259-62f5f7a4be8c12013-02-13
63323-104-50ML - Milliliter63323-1049fd84189-0583-49c6-819d-b325d158104512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETOPOSIDEACTIVE INGREDIENT6PLQ3CP4P3ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ETOPOSIDEACTIVE MOIETY6PLQ3CP4P3ETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90METOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETOPOSIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-104ETOPOSIDE (ETOPOSIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 9 package rows20220612_fe870629-104d-4d67-a7c6-f53bc588121e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310248etoposide 20 MG/ML Injectable SolutionPSNfe870629-104d-4d67-a7c6-f53bc588121e6
310248etoposide 20 MG/ML Injectable SolutionSCDfe870629-104d-4d67-a7c6-f53bc588121e6
310248etoposide (as etoposide phosphate) 20 MG/ML Injectable SolutionSYfe870629-104d-4d67-a7c6-f53bc588121e6
310248VP-16 20 MG/ML Injectable SolutionSYfe870629-104d-4d67-a7c6-f53bc588121e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-104-01633230104011 in 1 BOXHistorical
63323-104-056332301040510 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE10 box2001-07-180000-00-00NoNoCurrent
63323-104-06633230104061 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06) / 5 mL in 1 VIAL, MULTI-DOSE2022-09-090000-00-00NoNoCurrent
63323-104-25633230104251 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25) / 25 mL in 1 VIAL, MULTI-DOSE2001-07-180000-00-00NoNoCurrent
63323-104-50633230104501 VIAL, MULTI-DOSE in 1 CARTON (63323-104-50) / 50 mL in 1 VIAL, MULTI-DOSE2001-07-180000-00-00NoNoCurrent