Home NDC 0904-7199 Phenytoin
Product NDC 0904-7199
11-digit product format 009047199
Labeler code 0904
Product ID 0904-7199_066e29d5-dcad-4017-a345-085432105a41
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA200565
Marketing category ANDA
Marketing start 2014-04-17
Substance PHENYTOIN
Active strength 50 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
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 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 A200565-001 PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200565-001 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 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200565-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2014-04-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Phenytoin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYTOIN 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6158TKW0C5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1313885 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 0904-7199-07 Phenytoin 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 4 0904-7199-07 Phenytoin 30 in 1 CARTON TABLET, CHEWABLE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7199 PHENYTOIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20250125_08a9d26b-4419-43ec-98f3-43d4534c2e76.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 · 5 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 0904-7199-07 00904719907 30 BLISTER PACK in 1 CARTON (0904-7199-07) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 30 blister pack 2014-04-17 0000-00-00 No No Current