Eptifibatide

Product NDC
55150-218
11-digit product format
551500218
Labeler code
55150
Product ID
55150-218_944b269c-d810-411d-9ed4-8edd9d0ac1b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eptifibatide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA206127
Marketing category
ANDA
Marketing start
2015-12-08
Substance
EPTIFIBATIDE
Active strength
75 mg/100mL
Pharmacologic classes
Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPTIFIBATIDE75 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNA8320J834
Rxcui200349, 1736470, 1736477

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3f348a77-7d57-3778-5b96-18926a5b9ee8Product name920190319

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-218-99Eptifibatide100 mL in 1 VIAL, SINGLE-DOSEINJECTION1007
55150-218-99Eptifibatide1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-218-99ML - Milliliter55150-21815b4e0dc-385c-4039-8e01-b99cc882045e12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-218EPTIFIBATIDE INJECTION [EUGIA US LLC]7Current NDC, Legacy NDC, 2 package rows20240110_00ad7bbe-cadd-4647-b74b-adfc9f2b5e94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736470eptifibatide 20 MG in 10 ML InjectionPSN00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
1736477eptifibatide 200 MG in 100 ML InjectionPSN00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
200349eptifibatide 75 MG in 100 ML InjectionPSN00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
173647010 ML eptifibatide 2 MG/ML InjectionSCD00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
200349100 ML eptifibatide 0.75 MG/ML InjectionSCD00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
1736477100 ML eptifibatide 2 MG/ML InjectionSCD00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
1736470eptifibatide 20 MG per 10 ML InjectionSY00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
1736477eptifibatide 200 MG per 100 ML InjectionSY00ad7bbe-cadd-4647-b74b-adfc9f2b5e947
200349eptifibatide 75 MG per 100 ML InjectionSY00ad7bbe-cadd-4647-b74b-adfc9f2b5e947

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-218-99551500218991 VIAL, SINGLE-DOSE in 1 CARTON (55150-218-99) / 100 mL in 1 VIAL, SINGLE-DOSE2015-12-080000-00-00NoNoCurrent