Home NDC 70436-162 Eptifibatide
Product NDC 70436-162
11-digit product format 704360162
Labeler code 70436
Product ID 70436-162_4a614df8-4e1d-d610-e063-6294a90a7d7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eptifibatide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA209864
Marketing category ANDA
Marketing start 2019-06-01
Substance EPTIFIBATIDE
Active strength 2 mg/mL
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 A209864-001 EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 A209864-002 EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25
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 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION AP 2019-01-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION AP 2019-01-25 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPTIFIBATIDE 2 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 70436-162-80 Eptifibatide 10 mL in 1 VIAL INJECTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-162 EPTIFIBATIDE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20221125_2ab98ecd-c578-4032-a3d5-ae14d58d86a7.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 70436-162-80 70436016280 10 mL in 1 VIAL (70436-162-80) 10 ml 2020-12-01 0000-00-00 No No Current