Eptifibatide

Product NDC: 70860-305
11-digit product format: 708600305
Labeler code: 70860
Product ID: 70860-305_e03cf0a7-91aa-4b3c-83e7-393365faa816
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: eptifibatide
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA213081
Marketing category: ANDA
Marketing start: 2022-09-30
Marketing end: 0000-00-00
Substance: EPTIFIBATIDE
Active strength: 1 mg/mL
Pharmacologic classes: Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70860-305		D	Discontinued by firm		2026-08-10
excluded package	package	70860-305	70860-305-51	D	Discontinued by firm		2026-08-10

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70860-305-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70860-305-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70860-305-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70860-305-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70860-305-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70860-305-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70860-305-51	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70860-305-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70860-305-51	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70860-305-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70860-305-51	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213081-001	EPTIFIBATIDE	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP		2021-09-07
A213081-002	EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP		2022-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213081-001	AP
A213081-002	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 2 · 62 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
2026-02-19 14:30 UTC	2026-02	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213081-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2021-09-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213081-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2022-04-20	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213081-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213081-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213081-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213081-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213081-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213081-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213081-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213081-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213081-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213081-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213081-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213081-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213081-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213081-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213081-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213081-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213081-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213081-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213081-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213081-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213081-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213081-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213081-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213081-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213081-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213081-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213081-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213081-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213081-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213081-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213081-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213081-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213081-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213081-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213081-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213081-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213081-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213081-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213081-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213081-002	AP	1	`ea1830bbd6c7…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-305-51	2024-03-03	C162847	48780-1	1030e364-fe67-111a-e063-dadaa90a10e2	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
70860-305-51	2024-01-30	C162847	48780-1	1030e364-fe67-111a-e063-dadaa90a10e2	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-305-51	ML - Milliliter	70860-305	0fd73e21-cdfe-4da4-8bbd-d219fc75d4de	1	2023-03-13

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	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	c488f1af-a82c-4360-8886-79520635561a	2025-10-20	Warnings	Exact identifier application applno (ANDA): 213081 application number: ANDA213081
Eptifibatide	EPTIFIBATIDE	Avenacy, LLC	c0781dae-3ef6-4cab-b084-01d2e45f3764	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213081 application number: ANDA213081

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-305-51	70860030551	1 VIAL, SINGLE-DOSE in 1 CARTON (70860-305-51) > 100 mL in 1 VIAL, SINGLE-DOSE	2022-09-30	0000-00-00	No	No	Current