Home NDC 70518-0841 Phenytoin
Product NDC 70518-0841
11-digit product format 705180841
Labeler code 70518
Product ID 70518-0841_522f9466-a36b-e74a-e063-6394a90af379
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA200565
Marketing category ANDA
Marketing start 2017-11-10
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-0841 70518-0841-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-0841 70518-0841-1 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 70518-0841-0 Phenytoin 30 in 1 BLISTER PACK TABLET, CHEWABLE 30 17 70518-0841-1 Phenytoin 100 in 1 BOX TABLET, CHEWABLE 100 17 70518-0841-2 Phenytoin 1 in 1 POUCH TABLET, CHEWABLE 1 17 70518-0841-3 Phenytoin 50 in 1 BOX TABLET, CHEWABLE 50 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-0841 PHENYTOIN TABLET, CHEWABLE [REMEDYREPACK INC.] 12 Current NDC, Legacy NDC, 4 package rows 20250503_31e8a777-75b1-4f48-9682-0bcc3189ad26.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 70518-0841-0 70518084100 30 TABLET, CHEWABLE in 1 BLISTER PACK (70518-0841-0) 2017-11-10 0000-00-00 No No Current 70518-0841-1 70518084101 100 POUCH in 1 BOX (70518-0841-1) > 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2) 100 pouch 2022-01-05 0000-00-00 No No Current 70518-0841-2 70518084102 1 in 1 POUCH Historical 70518-0841-3 70518084103 50 POUCH in 1 BOX (70518-0841-3) / 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2) 50 pouch 2026-04-25 No No Current