ERIBULIN MESYLATE

Product NDC
0143-9167
11-digit product format
001439167
Labeler code
0143
Product ID
0143-9167_44675218-d4b3-04bc-e063-6394a90a1fbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eribulin mesylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HIKMA PHARMACEUTICALS USA INC.
Application
ANDA218281
Marketing category
ANDA
Marketing start
2024-06-28
Substance
ERIBULIN MESYLATE
Active strength
.5 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ERIBULIN MESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERIBULIN MESYLATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAV9U0660CW
Rxcui1045456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2cc096b-1048-9b7c-d909-76a5ea566cbfProduct name320251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9167-01ERIBULIN MESYLATE1 in 1 CARTONINJECTION19
0143-9167-01ERIBULIN MESYLATE2 mL in 1 VIAL, SINGLE-DOSEINJECTION29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9167-01ML - Milliliter0143-916718e7f209-5112-403f-978a-5935ed0eb83f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9167ERIBULIN MESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, 2 package rows20250328_aa69e7a5-fa82-4984-b9d2-653c772b80e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045456eriBULin mesylate 1 MG in 2 ML InjectionPSNaa69e7a5-fa82-4984-b9d2-653c772b80e39
10454562 ML eribulin mesylate 0.5 MG/ML InjectionSCDaa69e7a5-fa82-4984-b9d2-653c772b80e39
1045456eribulin mesylate 1 MG per 2 ML InjectionSYaa69e7a5-fa82-4984-b9d2-653c772b80e39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9167-01001439167011 VIAL, SINGLE-DOSE in 1 CARTON (0143-9167-01) / 2 mL in 1 VIAL, SINGLE-DOSE2024-06-28NoNoCurrent