Home NDC 43063-492 Extended Phenytoin Sodium
Product NDC 43063-492
11-digit product format 430630492
Labeler code 43063
Product ID 43063-492_db73d0d6-853a-11c6-e053-2a95a90a0f80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin Sodium
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA040765
Marketing category ANDA
Marketing start 2009-12-16
Marketing end 0000-00-00
Substance PHENYTOIN SODIUM
Active strength 100 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 2023-12-31
Current FDA listing Historical FDA.report record 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 product product 43063-492 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43063-492 43063-492-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A040765-001 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040765-001 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 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYTOIN SODIUM ACTIVE INGREDIENT 4182431BJH EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 MANNITOL INACTIVE INGREDIENT 3OWL53L36A EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-492 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 Legacy NDC 20241013_0666820e-9f59-4577-9e85-3454e80cba20.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-492-30 43063049230 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-492-30) 30 capsule 2012-04-25 0000-00-00 No No Current