FDA.reportPublic FDA data

Etoposide

Product NDC
68001-265
11-digit product format
680010265
Labeler code
68001
Product ID
68001-265_30d6f51a-8099-4ff9-9be6-fb0559c88e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etoposide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA074513
Marketing category
ANDA
Marketing start
2013-11-14
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
2ab98334-79be-46be-f4f5-d4a6cc04219eProduct name320180118
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4896aaa2-df52-a28b-a484-cf928e9408caProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
e9a73b62-e9c6-118b-a3be-022705d13855Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-265-22Etoposide5 mL in 1 VIAL, MULTI-DOSEINJECTION54
68001-265-23Etoposide25 mL in 1 VIAL, MULTI-DOSEINJECTION254
68001-265-24Etoposide50 mL in 1 VIAL, MULTI-DOSEINJECTION504
68001-265-25Etoposide1 in 1 BOXINJECTION14
68001-265-26Etoposide1 in 1 BOXINJECTION14
68001-265-27Etoposide1 in 1 BOXINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-265-22ML - Milliliter68001-265125f1d4d-09ac-45d5-a99e-0e997325926b12015-02-02
68001-265-23ML - Milliliter68001-26522ae106b-d496-45b7-ad03-74d49e31864912015-02-02
68001-265-24ML - Milliliter68001-265fb4b57af-a9d1-4d43-9ad3-ac24f7e692d612015-02-02
68001-265-25ML - Milliliter68001-265b97b91dd-d2d1-443e-a85a-a258dfecfeb712015-02-02
68001-265-26ML - Milliliter68001-265d4514414-dbd4-4f81-81ad-79fa1035167412015-02-02
68001-265-27ML - Milliliter68001-265baa1ec06-99d5-48aa-964e-30feae00d0d012015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETOPOSIDEACTIVE INGREDIENT6PLQ3CP4P3ETOPOSIDE INJECTION [BLUEPOINT LABORATORIES]2
ETOPOSIDEACTIVE MOIETY6PLQ3CP4P3ETOPOSIDE INJECTION [BLUEPOINT LABORATORIES]2
ALCOHOLINACTIVE INGREDIENT3K9958V90METOPOSIDE INJECTION [BLUEPOINT LABORATORIES]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLETOPOSIDE INJECTION [BLUEPOINT LABORATORIES]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHETOPOSIDE INJECTION [BLUEPOINT LABORATORIES]2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQETOPOSIDE INJECTION [BLUEPOINT LABORATORIES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETOPOSIDE INJECTION [BLUEPOINT LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-265ETOPOSIDE INJECTION [BLUEPOINT LABORATORIES]4Current NDC, Legacy NDC, 6 package rows20180621_157d4e0f-806d-4011-9dec-97e2449e507b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310248etoposide 20 MG/ML Injectable SolutionPSN157d4e0f-806d-4011-9dec-97e2449e507b4
310248etoposide 20 MG/ML Injectable SolutionSCD157d4e0f-806d-4011-9dec-97e2449e507b4
310248etoposide (as etoposide phosphate) 20 MG/ML Injectable SolutionSY157d4e0f-806d-4011-9dec-97e2449e507b4
310248VP-16 20 MG/ML Injectable SolutionSY157d4e0f-806d-4011-9dec-97e2449e507b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-265-22680010265225 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
68001-265-236800102652325 mL in 1 VIAL, MULTI-DOSE25 mlHistorical
68001-265-246800102652450 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
68001-265-25680010265251 VIAL, MULTI-DOSE in 1 BOX (68001-265-25) / 5 mL in 1 VIAL, MULTI-DOSE (68001-265-22) 2013-11-140000-00-00NoNoCurrent
68001-265-26680010265261 VIAL, MULTI-DOSE in 1 BOX (68001-265-26) / 25 mL in 1 VIAL, MULTI-DOSE (68001-265-23) 2013-11-140000-00-00NoNoCurrent
68001-265-27680010265271 VIAL, MULTI-DOSE in 1 BOX (68001-265-27) / 50 mL in 1 VIAL, MULTI-DOSE (68001-265-24) 2013-11-140000-00-00NoNoCurrent