Eptifibatide

Product NDC
62147-0602
11-digit product format
621470602
Labeler code
62147
Product ID
62147-0602_ef0ad483-9086-4267-9b57-fcedd868719c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eptifibatide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
USV Private Limited
Application
ANDA204362
Marketing category
ANDA
Marketing start
2020-01-01
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62147-0602-1Eptifibatide100 mL in 1 VIALINJECTION, SOLUTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62147-0602EPTIFIBATIDE INJECTION, SOLUTION [USV PRIVATE LIMITED]1Legacy NDC, 1 package rows20200101_ef0ad483-9086-4267-9b57-fcedd868719c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736477eptifibatide 200 MG in 100 ML InjectionPSNef0ad483-9086-4267-9b57-fcedd868719c1
200349eptifibatide 75 MG in 100 ML InjectionPSNef0ad483-9086-4267-9b57-fcedd868719c1
200349100 ML eptifibatide 0.75 MG/ML InjectionSCDef0ad483-9086-4267-9b57-fcedd868719c1
1736477100 ML eptifibatide 2 MG/ML InjectionSCDef0ad483-9086-4267-9b57-fcedd868719c1
1736477eptifibatide 200 MG per 100 ML InjectionSYef0ad483-9086-4267-9b57-fcedd868719c1
200349eptifibatide 75 MG per 100 ML InjectionSYef0ad483-9086-4267-9b57-fcedd868719c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62147-0602-162147060201100 mL in 1 VIAL (62147-0602-1) 100 ml2020-01-010000-00-00NoNoCurrent