Eptifibatide

Product NDC
72078-025
11-digit product format
720780025
Labeler code
72078
Product ID
72078-025_7af20acf-ba9f-4387-9729-85d3c137f41e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eptifibatide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA203258
Marketing category
ANDA
Marketing start
2021-04-01
Substance
EPTIFIBATIDE
Active strength
2 mg/mL
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
EPTIFIBATIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNA8320J834
Rxcui200349, 1736470, 1736477

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3f348a77-7d57-3778-5b96-18926a5b9ee8Product name920190319

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72078-025-10Eptifibatide10 mL in 1 VIALINJECTION, SOLUTION103
72078-025-10Eptifibatide1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72078-025-10ML - Milliliter72078-025e0776bb7-14a6-4bf4-9ea0-df912b739e7812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72078-025EPTIFIBATIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20210724_a7a89c59-22fb-41fd-b70a-ac2395717db1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736470eptifibatide 20 MG in 10 ML InjectionPSNa7a89c59-22fb-41fd-b70a-ac2395717db13
1736477eptifibatide 200 MG in 100 ML InjectionPSNa7a89c59-22fb-41fd-b70a-ac2395717db13
200349eptifibatide 75 MG in 100 ML InjectionPSNa7a89c59-22fb-41fd-b70a-ac2395717db13
173647010 ML eptifibatide 2 MG/ML InjectionSCDa7a89c59-22fb-41fd-b70a-ac2395717db13
200349100 ML eptifibatide 0.75 MG/ML InjectionSCDa7a89c59-22fb-41fd-b70a-ac2395717db13
1736477100 ML eptifibatide 2 MG/ML InjectionSCDa7a89c59-22fb-41fd-b70a-ac2395717db13
1736470eptifibatide 20 MG per 10 ML InjectionSYa7a89c59-22fb-41fd-b70a-ac2395717db13
1736477eptifibatide 200 MG per 100 ML InjectionSYa7a89c59-22fb-41fd-b70a-ac2395717db13
200349eptifibatide 75 MG per 100 ML InjectionSYa7a89c59-22fb-41fd-b70a-ac2395717db13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72078-025-10720780025101 VIAL in 1 CARTON (72078-025-10) / 10 mL in 1 VIAL1 vial2021-04-010000-00-00NoNoCurrent