Eptifibatide

Product NDC
70436-027
11-digit product format
704360027
Labeler code
70436
Product ID
70436-027_4a613f2d-85b3-d45c-e063-6294a90adb93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eptifibatide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA209864
Marketing category
ANDA
Marketing start
2019-07-22
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
70436-027-80Eptifibatide100 mL in 1 VIALINJECTION1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-027-80ML - Milliliter70436-027dcfa5e18-e18d-40aa-a80a-17048218316f12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-027EPTIFIBATIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20221125_da421d88-6c00-428a-82a6-b3b4f7a68b85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736470eptifibatide 20 MG in 10 ML InjectionPSNda421d88-6c00-428a-82a6-b3b4f7a68b856
200349eptifibatide 75 MG in 100 ML InjectionPSNda421d88-6c00-428a-82a6-b3b4f7a68b856
173647010 ML eptifibatide 2 MG/ML InjectionSCDda421d88-6c00-428a-82a6-b3b4f7a68b856
200349100 ML eptifibatide 0.75 MG/ML InjectionSCDda421d88-6c00-428a-82a6-b3b4f7a68b856
1736470eptifibatide 20 MG per 10 ML InjectionSYda421d88-6c00-428a-82a6-b3b4f7a68b856
200349eptifibatide 75 MG per 100 ML InjectionSYda421d88-6c00-428a-82a6-b3b4f7a68b856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-027-8070436002780100 mL in 1 VIAL (70436-027-80) 100 ml2019-07-220000-00-00NoNoCurrent