Home NDC 29300-379 Phenytoin Sodium
Product NDC 29300-379
11-digit product format 293000379
Labeler code 29300
Product ID 29300-379_a6527387-ec89-41a1-b85a-c0fb7b4a7db7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin Sodium
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA213834
Marketing category ANDA
Marketing start 2022-11-12
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 A213834-001 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13
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.
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 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2022-10-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2022-10-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2022-10-13 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213834-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL 2022-10-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-05-13 08:27 UTC 2023-05 A213834-001 AB 1 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213834-001 AB 1 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213834-001 AB 1 3a93d1ddd44b…
Additional Listing Data#
Finished product Yes
Brand name base 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 29300-379-01 Phenytoin Sodium 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 6 29300-379-05 Phenytoin Sodium 500 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 500 6 29300-379-10 Phenytoin Sodium 1000 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-379 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.] 6 Current NDC, Legacy NDC, 3 package rows 20221112_afdf66e0-5f99-444e-bc06-2fdddc507f5c.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 Marketing end Sample Exclude flag Status 29300-379-01 29300037901 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-01) 2022-11-12 0000-00-00 No No Current 29300-379-05 29300037905 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-05) 2022-11-12 0000-00-00 No No Current 29300-379-10 29300037910 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-10) 2022-11-12 0000-00-00 No No Current