Home NDC 68462-945 Fosphenytoin sodium
Product NDC 68462-945
11-digit product format 684620945
Labeler code 68462
Product ID 68462-945_47b1da2e-f5e6-4a4e-8a67-05732a4e20d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosphenytoin sodium
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler GLENMARK PHARMACEUTICALS INC., USA
Application ANDA214926
Marketing category ANDA
Marketing start 2025-05-28
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 2027-12-31
Current FDA listing Yes 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 A214926-001 FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214926-001 AP
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 2026-08-18 06:07:40 2026-07 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214926-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2023-10-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fosphenytoin sodium
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1670195 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 68462-945-10 Fosphenytoin sodium 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 3 68462-945-64 Fosphenytoin sodium 10 in 1 CARTON INJECTION, SOLUTION 10 3
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fosphenytoin sodium FOSPHENYTOIN SODIUM GLENMARK PHARMACEUTICALS INC., USA a0def32c-e693-43e5-9509-0cef9642441c 2026-02-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214926 application number: ANDA214926 Fosphenytoin sodium FOSPHENYTOIN SODIUM GLENMARK PHARMACEUTICALS INC., USA bb38bc6a-99c7-4cda-b3f0-37f629d060cf 2026-02-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214926 application number: ANDA214926 ndc (product): 68462-945 Fosphenytoin Sodium FOSPHENYTOIN SODIUM Sagent Pharmaceuticals e1dab8ad-cbf6-4273-92fa-02629de2abde 2024-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214926 application number: ANDA214926 Fosphenytoin sodium FOSPHENYTOIN SODIUM Gland Pharma Limited 49b08648-6a83-42c7-ae7b-80c29f2534fc 2023-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214926 application number: ANDA214926
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68462-945-10 68462094510 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 68462-945-64 68462094564 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-945-64) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-945-10) 2025-05-28 No No Current