Home NDC 51672-4146 Phenytoin
Product NDC 51672-4146
11-digit product format 516724146
Labeler code 51672
Product ID 51672-4146_4e03fb7d-d33a-2472-e063-6394a90a9b81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
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 51672-4146-1 Phenytoin 100 in 1 BOTTLE TABLET, CHEWABLE 100 13 51672-4146-3 Phenytoin 1000 in 1 BOTTLE TABLET, CHEWABLE 1000 13 51672-4146-6 Phenytoin 30 in 1 BOTTLE TABLET, CHEWABLE 30 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Phenytoin ACTIVE INGREDIENT 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 Phenytoin ACTIVE MOIETY 6158TKW0C5 PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 aluminum oxide INACTIVE INGREDIENT LMI26O6933 PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 Lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 Saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 Sucrose INACTIVE INGREDIENT C151H8M554 PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 Talc INACTIVE INGREDIENT 7SEV7J4R1U PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 5 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 51672-4146 PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC] 11 Current NDC, Legacy NDC, 3 package rows 20220702_78b38e7b-1460-4adc-b738-320ffa6259c2.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 Marketing start Marketing end Sample Exclude flag Status 51672-4146-1 51672414601 100 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-1) 2014-04-17 0000-00-00 No No Current 51672-4146-3 51672414603 1000 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-3) 2014-04-17 0000-00-00 No No Current 51672-4146-6 51672414606 30 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-6) 2014-04-17 0000-00-00 No No Current