Home NDC 60687-156 Phenytoin
Product NDC 60687-156
11-digit product format 606870156
Labeler code 60687
Product ID 60687-156_2397a208-617f-7289-e063-6394a90a37e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler American Health Packaging
Application ANDA200565
Marketing category ANDA
Marketing start 2015-12-02
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 2026-12-31
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 2026-12-31 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 60687-156-25 Phenytoin 30 in 1 BOX, UNIT-DOSE TABLET, CHEWABLE 30 8 60687-156-95 Phenytoin 1 in 1 BLISTER PACK TABLET, CHEWABLE 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Phenytoin ACTIVE INGREDIENT 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 Phenytoin ACTIVE MOIETY 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 Lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 Saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 Sucrose INACTIVE INGREDIENT C151H8M554 PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-156 PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING] 8 Current NDC, Legacy NDC, 2 package rows 20241010_352007dd-0587-4597-8338-c13eda4c5d63.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 60687-156-25 60687015625 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-156-25) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (60687-156-95) 30 blister pack 2015-12-02 0000-00-00 No No Current 60687-156-95 60687015695 1 in 1 BLISTER PACK Historical