Home NDC 72078-026 Eptifibatide
Product NDC 72078-026
11-digit product format 720780026
Labeler code 72078
Product ID 72078-026_7af20acf-ba9f-4387-9729-85d3c137f41e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eptifibatide
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA203258
Marketing category ANDA
Marketing start 2020-11-20
Substance EPTIFIBATIDE
Active strength .75 mg/mL
Pharmacologic classes Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A203258-001 EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 A203258-002 EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2018-07-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2018-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203258-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP RS 2018-07-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203258-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP RS 2018-07-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Eptifibatide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPTIFIBATIDE .75 mg/mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200349 Internal RxNorm lookup 1736470 Internal RxNorm lookup 1736477 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72078-026-10 Eptifibatide 1 in 1 CARTON INJECTION, SOLUTION 1 3 72078-026-10 Eptifibatide 100 mL in 1 VIAL INJECTION, SOLUTION 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72078-026 EPTIFIBATIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 3 Current NDC, Legacy NDC, 2 package rows 20210724_a7a89c59-22fb-41fd-b70a-ac2395717db1.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72078-026-10 72078002610 1 VIAL in 1 CARTON (72078-026-10) / 100 mL in 1 VIAL 1 vial 2020-11-20 0000-00-00 No No Current