Home NDC 39822-4050 PHENYTOIN SODIUM
Product NDC 39822-4050
11-digit product format 398224050
Labeler code 39822
Product ID 39822-4050_492a8728-d60f-41ea-bedd-ead7375f3ad5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENYTOIN SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler X-GEN Pharmaceuticals, Inc.
Application ANDA040573
Marketing category ANDA
Marketing start 2011-05-02
Marketing end 0000-00-00
Substance PHENYTOIN SODIUM
Active strength 50 mg/mL
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 E
Listing certified through 2017-12-31
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 · 39 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 39822-4050-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 39822-4050-6 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 39822-4050-3 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 39822-4050-6 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 39822-4050-3 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 39822-4050-6 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040573-001 PHENYTOIN SODIUM PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040573-001 AP
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 · 41 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 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040573-001 PHENYTOIN SODIUM 50MG/ML INJECTABLE / INJECTION AP 2006-09-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYTOIN SODIUM ACTIVE INGREDIENT 4182431BJH PHENYTOIN SODIUM INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] 9 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 PHENYTOIN SODIUM INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] 9 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PHENYTOIN SODIUM INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PHENYTOIN SODIUM INJECTION, SOLUTION [X-GEN PHARMACEUTICALS, INC.] 9
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 · 1 matching rows.