Home NDC 83634-301 Eptifibatide
Product NDC 83634-301
11-digit product format 836340301
Labeler code 83634
Product ID 83634-301_74e580c1-7f30-49cf-8e83-968bc05c5559
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eptifibatide
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avenacy Inc.
Application ANDA213081
Marketing category ANDA
Marketing start 2024-01-31
Marketing end 2027-11-30
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 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.
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 RLD / RS 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.
Additional Listing Data#
Finished product Yes
Brand name base Eptifibatide 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200349 Internal RxNorm lookup 1736470 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 83634-301-51 Eptifibatide 100 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 100 2 83634-301-51 Eptifibatide 1 in 1 CARTON INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83634-301 EPTIFIBATIDE INJECTION, SOLUTION [AVENACY INC.] 2 Current NDC, 2 package rows 20240820_c0781dae-3ef6-4cab-b084-01d2e45f3764.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 Marketing start Marketing end Sample Exclude flag Status 83634-301-51 83634030151 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-301-51) / 100 mL in 1 VIAL, SINGLE-DOSE 2024-01-31 2027-11-30 No No Historical