Home NDC 0378-3850-05 Phenytoin
Product NDC 0378-3850
Requested package NDC 0378-3850-05
11-digit product format 003783850
Labeler code 0378
Product ID 0378-3850_27a1d06e-f2f6-4219-b0e8-2af628ba62f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA200691
Marketing category ANDA
Marketing start 2012-12-26
Marketing end 2022-02-28
Substance PHENYTOIN
Active strength 50 mg/1
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 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A200691-001 PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200691-001 AB
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 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYTOIN ACTIVE INGREDIENT 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [MYLAN PHARMACEUTICALS INC.] 5 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [MYLAN PHARMACEUTICALS INC.] 5 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B PHENYTOIN TABLET, CHEWABLE [MYLAN PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENYTOIN TABLET, CHEWABLE [MYLAN PHARMACEUTICALS INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENYTOIN TABLET, CHEWABLE [MYLAN PHARMACEUTICALS INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENYTOIN TABLET, CHEWABLE [MYLAN PHARMACEUTICALS INC.] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U PHENYTOIN TABLET, CHEWABLE [MYLAN PHARMACEUTICALS INC.] 5 PHENYTOIN ACTIVE INGREDIENT 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 2 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B PHENYTOIN TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENYTOIN TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENYTOIN TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENYTOIN TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PHENYTOIN TABLET, CHEWABLE [MYLAN INSTITUTIONAL INC.] 2 PHENYTOIN ACTIVE INGREDIENT 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B PHENYTOIN TABLET, CHEWABLE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENYTOIN TABLET, CHEWABLE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENYTOIN TABLET, CHEWABLE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENYTOIN TABLET, CHEWABLE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PHENYTOIN TABLET, CHEWABLE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Phenytoin PHENYTOIN Rising Pharma Holdings, Inc. e95cad66-b5f9-4802-a35f-fed340bf09ab 2024-03-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200691 application number: ANDA200691
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-3850-05 00378385005 500 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-05) 2012-12-26 0000-00-00 No No Current