FDA.reportPublic FDA data

Eptifibatide

Product NDC
14335-070
11-digit product format
143350070
Labeler code
14335
Product ID
14335-070_c1fc3751-11fa-0ef5-e053-2a95a90a01de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eptifibatide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA209864
Marketing category
ANDA
Marketing start
2019-07-22
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
2022-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14335-070-012023-01-30C16284748780-1ba0f9c33-1ae1-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION. EPTIFIBATIDE injection, for intravenous use Initial U.S. Approval: 1998
14335-070-012021-05-10C16284748780-1ba0f9c33-1ae1-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION. EPTIFIBATIDE injection, for intravenous use Initial U.S. Approval: 1998
14335-070-012021-01-29C16284748780-1ba0f9c33-1ae1-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION. EPTIFIBATIDE injection, for intravenous use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14335-070-01Eptifibatide10 mL in 1 VIALINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-070EPTIFIBATIDE INJECTION [HAINAN POLY PHARM. CO., LTD.]2Legacy NDC, 1 package rows20210511_80b86c46-230c-0090-e053-2991aa0a8fc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736470eptifibatide 20 MG in 10 ML InjectionPSN80b86c46-230c-0090-e053-2991aa0a8fc12
200349eptifibatide 75 MG in 100 ML InjectionPSN80b86c46-230c-0090-e053-2991aa0a8fc12
173647010 ML eptifibatide 2 MG/ML InjectionSCD80b86c46-230c-0090-e053-2991aa0a8fc12
200349100 ML eptifibatide 0.75 MG/ML InjectionSCD80b86c46-230c-0090-e053-2991aa0a8fc12
1736470eptifibatide 20 MG per 10 ML InjectionSY80b86c46-230c-0090-e053-2991aa0a8fc12
200349eptifibatide 75 MG per 100 ML InjectionSY80b86c46-230c-0090-e053-2991aa0a8fc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14335-070-011433500700110 mL in 1 VIAL (14335-070-01) 10 ml2019-07-220000-00-00NoNoCurrent