FDA.reportPublic FDA data

ETOPOPHOS

Product NDC
61269-410
11-digit product format
612690410
Labeler code
61269
Product ID
61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etoposide phosphate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
H2-Pharma, LLC
Application
NDA020457
Marketing category
NDA
Marketing start
2009-06-01
Substance
ETOPOSIDE PHOSPHATE
Active strength
100 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
ETOPOPHOS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOPOSIDE PHOSPHATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii528XYJ8L1N
Rxcui226719, 1734340

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61269-410-202025-02-01C16284748780-12cef2736-af43-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ETOPOPHOS safely and effectively. See full prescribing information for ETOPOPHOS. ETOPOPHOS ® (etoposide phosphate) for injection, for intravenous use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-410-20ETOPOPHOS1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,122
61269-410-20ETOPOPHOS1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-410-20EA - Each61269-410c118ffec-331c-404d-a9a6-add05f89779e12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-410ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [H2-PHARMA, LLC]21Current NDC, Legacy NDC, 2 package rows20250202_7499fc35-fae8-44ad-bbab-9a1a589bf3ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226719ETOPOPHOS 100 MG InjectionPSN7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
1734340etoposide 100 MG InjectionPSN7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
226719etoposide 100 MG Injection [Etopophos]SBD7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
1734340etoposide 100 MG InjectionSCD7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
226719Etopophos 100 MG (as etoposide phosphate) InjectionSY7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
226719Etopophos 100 MG InjectionSY7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
1734340etoposide 100 MG (as etoposide phosphate) InjectionSY7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
1734340VP-16 100 MG InjectionSY7499fc35-fae8-44ad-bbab-9a1a589bf3ee22
226719VP-16 100 MG Injection [Etopophos]SY7499fc35-fae8-44ad-bbab-9a1a589bf3ee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61269-410-20612690410201 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2009-06-010000-00-00NoNoCurrent