Home NDC 53002-1501 PHENYTOIN SODIUM
Product NDC 53002-1501
11-digit product format 530021501
Labeler code 53002
Product ID 53002-1501_5c315d08-f19f-406a-a737-c7ae373fab1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENYTOIN SODIUM
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA040621
Marketing category ANDA
Marketing start 2006-12-12
Marketing end 0000-00-00
Substance PHENYTOIN SODIUM
Active strength 100 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 33 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-1501-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-1501-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-1501-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-1501-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-1501-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-1501-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-1501-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-1501-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-1501-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-1501-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-1501-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-1501-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-1501-3 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-1501-0 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-1501-3 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-1501-0 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-1501-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-1501-0 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53002-1501-0 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53002-1501-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-1501-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-1501-0 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040621-001 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11
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 · 42 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 2026-08-18 06:07:40 2026-07 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2006-12-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040621-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2006-12-11 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A040621-001 AB 1 ea99ee380514…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-1501-0 2025-01-30 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-3 2025-01-30 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-0 2023-06-07 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-3 2023-06-07 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-0 2023-01-30 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-3 2023-01-30 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-0 2020-12-15 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-3 2020-12-15 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-0 2020-01-31 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953 53002-1501-3 2020-01-31 These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-1501-0 PHENYTOIN SODIUM 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 5 53002-1501-3 PHENYTOIN SODIUM 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-1501 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.] 5 Legacy NDC, 2 package rows 20230609_7f20cf98-1a63-4eaf-a7ac-fa5d79a045e0.zip
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 53002-1501-0 53002150100 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-0) 2017-09-01 0000-00-00 No No Current 53002-1501-3 53002150103 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53002-1501-3) 2017-09-01 0000-00-00 No No Current