Home NDC 65162-212 Extended Phenytoin Sodium
Product NDC 65162-212
11-digit product format 651620212
Labeler code 65162
Product ID 65162-212_ba4af35a-0bb4-4c62-bf75-174b2b5a5aba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenytoin Sodium
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA040765
Marketing category ANDA
Marketing start 2009-12-16
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040765-001 EXTENDED PHENYTOIN SODIUM 100MG EXTENDED CAPSULE / ORAL AB 2008-11-12 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Extended 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-212-03 Extended Phenytoin Sodium 30 in 1 BOTTLE CAPSULE 30 27 65162-212-10 Extended Phenytoin Sodium 100 in 1 BOTTLE CAPSULE 100 27 65162-212-11 Extended Phenytoin Sodium 1000 in 1 BOTTLE CAPSULE 1000 27 65162-212-50 Extended Phenytoin Sodium 500 in 1 BOTTLE CAPSULE 500 27
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 [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 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 PHENYTOIN SODIUM ACTIVE INGREDIENT 4182431BJH EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 PHENYTOIN SODIUM ACTIVE INGREDIENT 4182431BJH EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING] 4 PHENYTOIN SODIUM ACTIVE INGREDIENT 4182431BJH EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PHENYTOIN SODIUM ACTIVE INGREDIENT 4182431BJH PHENYTOIN SODIUM CAPSULE [DIRECT RX] 1 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 PHENYTOIN SODIUM CAPSULE [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-212 EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS LLC] 26 Current NDC, Legacy NDC, 4 package rows 20241027_7e467c02-49a0-4b62-b537-430fdfa4f10e.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 65162-212-03 65162021203 30 CAPSULE in 1 BOTTLE (65162-212-03) 30 capsule 2009-12-16 0000-00-00 No No Current 65162-212-10 65162021210 100 CAPSULE in 1 BOTTLE (65162-212-10) 100 capsule 2009-12-16 0000-00-00 No No Current 65162-212-11 65162021211 1000 CAPSULE in 1 BOTTLE (65162-212-11) 1000 capsule 2009-12-16 0000-00-00 No No Current 65162-212-50 65162021250 500 CAPSULE in 1 BOTTLE (65162-212-50) 500 capsule 2009-12-16 0000-00-00 No No Current