Eptifibatide

Product NDC: 0338-9559
Requested package NDC: 0338-9559-20
11-digit product format: 003389559
Labeler code: 0338
Product ID: 0338-9559_c8051921-bbb9-4a3b-a930-f179dce2181b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eptifibatide
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: ANDA208554
Marketing category: ANDA
Marketing start: 2019-02-01
Marketing end: 0000-00-00
Substance: EPTIFIBATIDE
Active strength: 200 mg/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0338-9559	0338-9559-20	D	Discontinued by firm		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 · 12 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…`

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
A208554-001	EPTIFIBATIDE	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION			2018-11-23
A208554-002	EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP		2018-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208554-002	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	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION		2018-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2018-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2018-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2018-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2018-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208554-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	2018-11-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208554-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	2018-11-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 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	A208554-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208554-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208554-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208554-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208554-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208554-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208554-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208554-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208554-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208554-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208554-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208554-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208554-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208554-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208554-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208554-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208554-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208554-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208554-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208554-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208554-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208554-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208554-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208554-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208554-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208554-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208554-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208554-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208554-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208554-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208554-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208554-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208554-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208554-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208554-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208554-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208554-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208554-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208554-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208554-001	AP	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eptifibatide	EPTIFIBATIDE	Baxter Healthcare Company	5f46b76b-5c83-49b9-ada8-4ad5cf81a38c	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208554 application number: ANDA208554

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
0338-9559-20	00338955920	1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9559-20) > 100 mL in 1 VIAL, SINGLE-DOSE	2019-02-01	0000-00-00	No	No	Current