eptifibatide

Product NDC
25021-409
11-digit product format
250210409
Labeler code
25021
Product ID
25021-409_130aef4e-e726-4067-8f51-17d0299c5453
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eptifibatide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA204693
Marketing category
ANDA
Marketing start
2018-07-15
Marketing end
0000-00-00
Substance
EPTIFIBATIDE
Active strength
2 mg/mL
Pharmacologic classes
Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
25021-409-10eptifibatide10 mL in 1 VIALINJECTION, SOLUTION106
25021-409-10eptifibatide1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-409-10ML - Milliliter25021-409d79397ee-830a-41b5-bace-2031faf12cd112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-409EPTIFIBATIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6Legacy NDC, 2 package rows20241024_a0d18778-0194-461a-a4ea-b2fca5df57c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736470eptifibatide 20 MG in 10 ML InjectionPSNa0d18778-0194-461a-a4ea-b2fca5df57c36
200349eptifibatide 75 MG in 100 ML InjectionPSNa0d18778-0194-461a-a4ea-b2fca5df57c36
173647010 ML eptifibatide 2 MG/ML InjectionSCDa0d18778-0194-461a-a4ea-b2fca5df57c36
200349100 ML eptifibatide 0.75 MG/ML InjectionSCDa0d18778-0194-461a-a4ea-b2fca5df57c36
1736470eptifibatide 20 MG per 10 ML InjectionSYa0d18778-0194-461a-a4ea-b2fca5df57c36
200349eptifibatide 75 MG per 100 ML InjectionSYa0d18778-0194-461a-a4ea-b2fca5df57c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-409-10250210409101 VIAL in 1 CARTON (25021-409-10) > 10 mL in 1 VIAL1 vial2018-07-150000-00-00NoNoCurrent