Home NDC 61919-815-71 PHENYTOIN SODIUM
Product NDC 61919-815
Requested package NDC 61919-815-71
11-digit product format 619190815
Labeler code 61919
Product ID 61919-815_4bd28a50-22df-5238-e063-6294a90a6eec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENYTOIN SODIUM
Dosage form CAPSULE
Route ORAL
Labeler DIRECT RX
Application ANDA040765
Marketing category ANDA
Marketing start 2014-01-01
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 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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.
Additional Listing Data#
Finished product Yes
Brand name base PHENYTOIN SODIUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYTOIN SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4182431BJH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855671 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-815-30 PHENYTOIN SODIUM 30 in 1 BOTTLE CAPSULE 30 4 61919-815-71 PHENYTOIN SODIUM 100 in 1 BOTTLE CAPSULE 100 4 61919-815-72 PHENYTOIN SODIUM 120 in 1 BOTTLE CAPSULE 120 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-815 PHENYTOIN SODIUM CAPSULE [DIRECT RX] 3 Current NDC, Legacy NDC, 3 package rows 20200130_df0bf42b-ce9a-42c3-8c24-46f1ea3bd214.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.
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 61919-815-71 61919081571 100 CAPSULE in 1 BOTTLE (61919-815-71) 100 capsule 2014-01-01 0000-00-00 No No Current