Home NDC 63739-911 Eptifibatide
Product NDC 63739-911
11-digit product format 637390911
Labeler code 63739
Product ID 63739-911_a1cdeb24-4e68-60dd-e053-2995a90a2b23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eptifibatide Injection
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler McKesson Corporation dba SKY Packaging
Application ANDA207864
Marketing category ANDA
Marketing start 2020-03-20
Marketing end 0000-00-00
Substance EPTIFIBATIDE
Active strength 20 mg/10mL
Pharmacologic classes Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63739-911-14 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63739-911-14 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63739-911-14 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63739-911-14 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63739-911-14 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63739-911-14 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63739-911-14 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63739-911-14 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63739-911-14 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63739-911-14 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63739-911-14 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63739-911-14 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 A207864-001 EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 A207864-002 EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20
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 · 76 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 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207864-001 EPTIFIBATIDE 2MG/ML INJECTABLE / INJECTION 2020-03-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207864-002 EPTIFIBATIDE 75MG/100ML INJECTABLE / INJECTION 2020-03-20 782e0a99824c…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63739-911-14 63739091114 1 VIAL in 1 CARTON (63739-911-14) > 10 mL in 1 VIAL 1 vial 2020-03-20 0000-00-00 No No Current