Home NDC 65162-998 Fosphenytoin Sodium
Product NDC 65162-998
11-digit product format 651620998
Labeler code 65162
Product ID 65162-998_757ffbac-e93f-4e0c-b3d2-0d29179b174b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosphenytoin Sodium
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA078476
Marketing category ANDA
Marketing start 2013-05-17
Substance FOSPHENYTOIN SODIUM
Active strength 50 mg/mL
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65162-998-25 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65162-998-25 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 A078476-001 FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18
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 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2008-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2008-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2008-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2008-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078476-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION 2008-03-18 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fosphenytoin Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSPHENYTOIN SODIUM 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7VLR55452Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1670195 Internal RxNorm lookup 1670200 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 65162-998-01 Fosphenytoin Sodium 2 mL in 1 VIAL INJECTION 2 16 65162-998-25 Fosphenytoin Sodium 25 in 1 CARTON INJECTION 25 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-998 FOSPHENYTOIN SODIUM INJECTION [AMNEAL PHARMACEUTICALS LLC] 16 Current NDC, Legacy NDC, 2 package rows 20241027_87ff8a91-5b37-401c-b75c-dc6efd348761.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 Units Marketing start Marketing end Sample Exclude flag Status 65162-998-01 65162099801 2 mL in 1 VIAL 2 ml Historical 65162-998-25 65162099825 25 VIAL in 1 CARTON (65162-998-25) / 2 mL in 1 VIAL (65162-998-01) 25 vial 2013-05-17 0000-00-00 No No Current