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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct14335-070IInactivated by FDA2026-08-17
excluded packagepackage14335-07014335-070-01IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14335-070-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14335-070-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14335-070-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage14335-070-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage14335-070-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage14335-070-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14335-070-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14335-070-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14335-070-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14335-070-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14335-070-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14335-070-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14335-070-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14335-070-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14335-070-011332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209864-001EPTIFIBATIDEEPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25
A209864-002EPTIFIBATIDEEPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209864-001AP
A209864-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25caaa826d4ba7…
2026-08-18 06:07:402026-07A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209864-001EPTIFIBATIDE2MG/MLINJECTABLE / INJECTIONAP2019-01-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209864-002EPTIFIBATIDE75MG/100MLINJECTABLE / INJECTIONAP2019-01-25bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209864-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A209864-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209864-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209864-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209864-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209864-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209864-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209864-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209864-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209864-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209864-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209864-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209864-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209864-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209864-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209864-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209864-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209864-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209864-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209864-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209864-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209864-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209864-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209864-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209864-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209864-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209864-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209864-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209864-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209864-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209864-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209864-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209864-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209864-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209864-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209864-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209864-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209864-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209864-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209864-002AP1bb7c543d1eb4…

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
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EptifibatideEPTIFIBATIDESlate Run Pharmaceuticals, LLCda421d88-6c00-428a-82a6-b3b4f7a68b852026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209864
application number: ANDA209864
EptifibatideEPTIFIBATIDESlate Run Pharmaceuticals, LLC2ab98ecd-c578-4032-a3d5-ae14d58d86a72026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209864
application number: ANDA209864

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