Home NDC 60687-841 Extended Phenytoin Sodium
Product NDC 60687-841
11-digit product format 606870841
Labeler code 60687
Product ID 60687-841_2d7feada-3c36-9b2e-e063-6294a90ab409
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin Sodium
Dosage form CAPSULE
Route ORAL
Labeler American Health Packaging
Application ANDA204309
Marketing category ANDA
Marketing start 2025-02-06
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 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 A204309-001 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204309-001 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 A204309-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204309-001 PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2015-06-10 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 Extended Phenytoin Sodium
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60687-841-01 Extended Phenytoin Sodium 100 in 1 CARTON CAPSULE 100 2 60687-841-11 Extended Phenytoin Sodium 1 in 1 BLISTER PACK CAPSULE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-841 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 2 Current NDC, 2 package rows 20250209_5b64cb11-673a-41ec-9b2a-1e194ae5eb0c.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 Units Marketing start Sample Exclude flag Status 60687-841-01 60687084101 100 BLISTER PACK in 1 CARTON (60687-841-01) / 1 CAPSULE in 1 BLISTER PACK (60687-841-11) 100 blister pack 2025-02-06 No No Current 60687-841-11 60687084111 1 in 1 BLISTER PACK Historical