Home NDC 70518-2554 Phenytoin
Product NDC 70518-2554
11-digit product format 705182554
Labeler code 70518
Product ID 70518-2554_9ddf7b40-441f-dc0d-e053-2995a90a5267
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form SUSPENSION
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA040610
Marketing category ANDA
Marketing start 2020-01-23
Marketing end 0000-00-00
Substance PHENYTOIN
Active strength 125 mg/5mL
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-2554-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-2554-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-2554-0 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-2554-0 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-2554-0 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-2554-0 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-2554-0 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-2554-0 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-2554-0 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-2554-0 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-2554-0 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-2554-0 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 70518-2554-0 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 70518-2554-0 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 70518-2554-0 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2022-04-08 23:34 UTC 2022-04 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040610-001 PHENYTOIN 125MG/5ML SUSPENSION / ORAL AB 2005-08-18 ea99ee380514…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-2554-0 70518255400 10 CUP in 1 BOX (70518-2554-0) > 10 mL in 1 CUP (70518-2554-1) 10 cup 2020-01-23 0000-00-00 No No Current