FDA.reportPublic FDA data

Etoposide

Product NDC
16729-114
11-digit product format
167290114
Labeler code
16729
Product ID
16729-114_364ac37e-94f0-0dad-e063-6394a90aae33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etoposide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
ANDA074513
Marketing category
ANDA
Marketing start
2015-03-03
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
16729-114-08Etoposide1 in 1 BOXINJECTION17
16729-114-08Etoposide25 mL in 1 VIAL, MULTI-DOSEINJECTION257
16729-114-11Etoposide50 mL in 1 VIAL, MULTI-DOSEINJECTION507
16729-114-11Etoposide1 in 1 BOXINJECTION17
16729-114-31Etoposide1 in 1 BOXINJECTION17
16729-114-31Etoposide5 mL in 1 VIAL, MULTI-DOSEINJECTION57
16729-114-32Etoposide1 in 1 BOXINJECTION17
16729-114-32Etoposide12.5 mL in 1 VIAL, MULTI-DOSEINJECTION12.57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-114-08ML - Milliliter16729-1145569fd0f-79b9-4952-91a8-7cfdc4b1640c12015-06-09
16729-114-11ML - Milliliter16729-114dd1fb6af-7888-4e98-a5cd-2c34d930044612015-06-09
16729-114-31ML - Milliliter16729-114535c713e-edb1-430f-9702-51cee4cdbccd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETOPOSIDEACTIVE INGREDIENT6PLQ3CP4P3ETOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]3
ETOPOSIDEACTIVE MOIETY6PLQ3CP4P3ETOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90METOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLETOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHETOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]3
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQETOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HETOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-114ETOPOSIDE INJECTION [ACCORD HEALTHCARE INC.]6Current NDC, Legacy NDC, 8 package rows20241004_4f850eb2-3542-43a0-90e8-bb37fa05cf15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310248etoposide 20 MG/ML Injectable SolutionPSN4f850eb2-3542-43a0-90e8-bb37fa05cf157
310248etoposide 20 MG/ML Injectable SolutionSCD4f850eb2-3542-43a0-90e8-bb37fa05cf157
310248etoposide (as etoposide phosphate) 20 MG/ML Injectable SolutionSY4f850eb2-3542-43a0-90e8-bb37fa05cf157
310248VP-16 20 MG/ML Injectable SolutionSY4f850eb2-3542-43a0-90e8-bb37fa05cf157

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-114-08167290114081 VIAL, MULTI-DOSE in 1 BOX (16729-114-08) / 25 mL in 1 VIAL, MULTI-DOSE2015-03-030000-00-00NoNoCurrent
16729-114-11167290114111 VIAL, MULTI-DOSE in 1 BOX (16729-114-11) / 50 mL in 1 VIAL, MULTI-DOSE2015-03-030000-00-00NoNoCurrent
16729-114-31167290114311 VIAL, MULTI-DOSE in 1 BOX (16729-114-31) / 5 mL in 1 VIAL, MULTI-DOSE2015-03-220000-00-00NoNoCurrent
16729-114-32167290114321 VIAL, MULTI-DOSE in 1 BOX (16729-114-32) > 12.5 mL in 1 VIAL, MULTI-DOSE2020-01-010000-00-00NoNoCurrent