Eptifibatide

Product NDC
70436-163
11-digit product format
704360163
Labeler code
70436
Product ID
70436-163_4a614df8-4e1d-d610-e063-6294a90a7d7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eptifibatide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA209864
Marketing category
ANDA
Marketing start
2019-06-01
Substance
EPTIFIBATIDE
Active strength
.75 mg/mL
Pharmacologic classes
Decreased Platelet Aggregation [PE], Platelet Aggregation 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
Eptifibatide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPTIFIBATIDE.75 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNA8320J834
Rxcui200349, 1736470

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
70436-163-80Eptifibatide100 mL in 1 VIALINJECTION1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-163-80ML - Milliliter70436-16340714e7b-f534-41b0-adb6-4c0f40e7dade12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-163EPTIFIBATIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20221125_2ab98ecd-c578-4032-a3d5-ae14d58d86a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736470eptifibatide 20 MG in 10 ML InjectionPSN2ab98ecd-c578-4032-a3d5-ae14d58d86a76
200349eptifibatide 75 MG in 100 ML InjectionPSN2ab98ecd-c578-4032-a3d5-ae14d58d86a76
173647010 ML eptifibatide 2 MG/ML InjectionSCD2ab98ecd-c578-4032-a3d5-ae14d58d86a76
200349100 ML eptifibatide 0.75 MG/ML InjectionSCD2ab98ecd-c578-4032-a3d5-ae14d58d86a76
1736470eptifibatide 20 MG per 10 ML InjectionSY2ab98ecd-c578-4032-a3d5-ae14d58d86a76
200349eptifibatide 75 MG per 100 ML InjectionSY2ab98ecd-c578-4032-a3d5-ae14d58d86a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-163-8070436016380100 mL in 1 VIAL (70436-163-80) 100 ml2020-12-010000-00-00NoNoCurrent