Eptifibatide

Product NDC: 0338-9558
11-digit product format: 003389558
Labeler code: 0338
Product ID: 0338-9558_a90f397a-95b8-421c-9e34-b327671f97a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eptifibatide
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: ANDA208554
Marketing category: ANDA
Marketing start: 2019-02-01
Substance: EPTIFIBATIDE
Active strength: 75 mg/100mL
Pharmacologic classes: Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Eptifibatide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPTIFIBATIDE	75 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NA8320J834	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200349	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5f46b76b-5c83-49b9-ada8-4ad5cf81a38c	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-9558-10	Eptifibatide	100 mL in 1 VIAL, SINGLE-DOSE	INJECTION	100		13
0338-9558-10	Eptifibatide	1 in 1 CARTON	INJECTION	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9558-10	ML - Milliliter	0338-9558	58b5e423-811c-44c5-b4b6-8e95698d6920	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9558	EPTIFIBATIDE INJECTION [BAXTER HEALTHCARE CORPORATION]	11	Current NDC, Legacy NDC, 2 package rows	20240601_5f46b76b-5c83-49b9-ada8-4ad5cf81a38c.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 · 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 ndc (product): 0338-9558

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
200349	eptifibatide 75 MG in 100 ML Injection	PSN	5f46b76b-5c83-49b9-ada8-4ad5cf81a38c	13
200349	100 ML eptifibatide 0.75 MG/ML Injection	SCD	5f46b76b-5c83-49b9-ada8-4ad5cf81a38c	13
200349	eptifibatide 75 MG per 100 ML Injection	SY	5f46b76b-5c83-49b9-ada8-4ad5cf81a38c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-9558-10	00338955810	1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE	2019-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eptifibatide	Baxter Healthcare Company \| Baxter Healthcare Corporation	2024-05-29	HUMAN PRESCRIPTION DRUG LABEL	13