Eptifibatide

Product NDC: 14335-070
Requested package NDC: 14335-070-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	14335-070	14335-070-01	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209864-001	EPTIFIBATIDE	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP		2019-01-25
A209864-002	EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP		2019-01-25

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209864-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2019-01-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209864-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2019-01-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209864-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209864-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209864-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209864-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209864-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209864-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209864-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209864-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209864-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209864-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209864-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209864-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209864-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209864-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209864-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209864-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209864-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209864-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209864-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209864-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209864-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209864-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209864-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209864-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209864-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209864-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209864-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209864-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209864-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209864-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209864-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209864-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209864-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209864-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209864-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209864-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209864-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209864-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209864-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209864-002	AP	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3f348a77-7d57-3778-5b96-18926a5b9ee8	Product name	9	20190319

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
14335-070-01	2023-01-30	C162847	48780-1	ba0f9c33-1ae1-a910-e053-dadaa90a0b85	These 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
14335-070-01	2021-05-10	C162847	48780-1	ba0f9c33-1ae1-a910-e053-dadaa90a0b85	These 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
14335-070-01	2021-01-29	C162847	48780-1	ba0f9c33-1ae1-a910-e053-dadaa90a0b85	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
14335-070-01	Eptifibatide	10 mL in 1 VIAL	INJECTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14335-070	EPTIFIBATIDE INJECTION [HAINAN POLY PHARM. CO., LTD.]	2	Legacy NDC, 1 package rows	20210511_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eptifibatide	EPTIFIBATIDE	Slate Run Pharmaceuticals, LLC	da421d88-6c00-428a-82a6-b3b4f7a68b85	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209864 application number: ANDA209864
Eptifibatide	EPTIFIBATIDE	Slate Run Pharmaceuticals, LLC	2ab98ecd-c578-4032-a3d5-ae14d58d86a7	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209864 application number: ANDA209864

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NA8320J834	EPTIFIBATIDE	188627-80-7	EPTIFIBATIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736470	eptifibatide 20 MG in 10 ML Injection	PSN	80b86c46-230c-0090-e053-2991aa0a8fc1	2
200349	eptifibatide 75 MG in 100 ML Injection	PSN	80b86c46-230c-0090-e053-2991aa0a8fc1	2
1736470	10 ML eptifibatide 2 MG/ML Injection	SCD	80b86c46-230c-0090-e053-2991aa0a8fc1	2
200349	100 ML eptifibatide 0.75 MG/ML Injection	SCD	80b86c46-230c-0090-e053-2991aa0a8fc1	2
1736470	eptifibatide 20 MG per 10 ML Injection	SY	80b86c46-230c-0090-e053-2991aa0a8fc1	2
200349	eptifibatide 75 MG per 100 ML Injection	SY	80b86c46-230c-0090-e053-2991aa0a8fc1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
14335-070-01	14335007001	10 mL in 1 VIAL (14335-070-01)	10 ml	2019-07-22	0000-00-00	No	No	Current