Home NDC 64980-573 Phenytoin
Product NDC 64980-573
11-digit product format 649800573
Labeler code 64980
Product ID 64980-573_14ec4c18-fa7a-46e6-ac18-a7c23253e51c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA200691
Marketing category ANDA
Marketing start 2024-05-03
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 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.
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 64980-573-01 Phenytoin 100 in 1 BOTTLE TABLET, CHEWABLE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-573 PHENYTOIN TABLET, CHEWABLE [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 1 package rows 20240504_e95cad66-b5f9-4802-a35f-fed340bf09ab.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 64980-573-01 64980057301 100 TABLET, CHEWABLE in 1 BOTTLE (64980-573-01) 2024-05-03 No No Current