Vinorelbine

Product NDC
25021-204
11-digit product format
250210204
Labeler code
25021
Product ID
25021-204_dfa03517-f452-450c-8eb6-d946c0350248
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vinorelbine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA091106
Marketing category
ANDA
Marketing start
2014-09-15
Substance
VINORELBINE TARTRATE
Active strength
10 mg/mL
Pharmacologic classes
Vinca Alkaloid [EPC], Vinca Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vinorelbine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VINORELBINE TARTRATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii253GQW851Q
Rxcui1729418, 1729422

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0783135f-b5b1-0ee3-83b5-6d0aaa75e170Product name220180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-204-01Vinorelbine1 mL in 1 VIALINJECTION, SOLUTION110
25021-204-01Vinorelbine1 in 1 CARTONINJECTION, SOLUTION110
25021-204-05Vinorelbine5 mL in 1 VIALINJECTION, SOLUTION510
25021-204-05Vinorelbine1 in 1 CARTONINJECTION, SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-204-01ML - Milliliter25021-204d9601aec-26e0-48b0-bb97-bb9f48f61e2412012-07-24
25021-204-05ML - Milliliter25021-2046b3d89d6-751e-4930-81f5-a714e31087ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
vinorelbine tartrateACTIVE INGREDIENT253GQW851QVINORELBINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]4
vinorelbineACTIVE MOIETYQ6C979R91YVINORELBINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]4
waterINACTIVE INGREDIENT059QF0KO0RVINORELBINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-204VINORELBINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10Current NDC, Legacy NDC, 4 package rows20240918_10a70995-e04d-4044-b1dc-c9aa27460397.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729418vinorelbine 10 MG in 1 ML InjectionPSN10a70995-e04d-4044-b1dc-c9aa2746039710
1729422vinorelbine 50 MG in 5 ML InjectionPSN10a70995-e04d-4044-b1dc-c9aa2746039710
17294181 ML vinorelbine 10 MG/ML InjectionSCD10a70995-e04d-4044-b1dc-c9aa2746039710
17294225 ML vinorelbine 10 MG/ML InjectionSCD10a70995-e04d-4044-b1dc-c9aa2746039710
1729418vinorelbine (as vinorelbine tartrate) 10 MG per 1 ML InjectionSY10a70995-e04d-4044-b1dc-c9aa2746039710
1729422vinorelbine (as vinorelbine tartrate) 50 mg per 5 ML InjectionSY10a70995-e04d-4044-b1dc-c9aa2746039710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-204-01250210204011 VIAL in 1 CARTON (25021-204-01) / 1 mL in 1 VIAL1 vial2014-09-150000-00-00NoNoCurrent
25021-204-05250210204051 VIAL in 1 CARTON (25021-204-05) / 5 mL in 1 VIAL1 vial2014-09-150000-00-00NoNoCurrent