Home NDC 0641-6137 Fosphenytoin Sodium
Product NDC 0641-6137
11-digit product format 006416137
Labeler code 0641
Product ID 0641-6137_d276be92-654c-4912-8dc5-3e148c835523
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosphenytoin Sodium
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA077989
Marketing category ANDA
Marketing start 2007-08-06
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 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 A077989-001 FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077989-001 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.
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 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077989-001 FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE / INJECTION AP 2007-08-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0641-6137-01 Fosphenytoin Sodium 10 mL in 1 VIAL INJECTION 10 22 0641-6137-10 Fosphenytoin Sodium 10 in 1 CARTON INJECTION 10 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6137 FOSPHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.] 22 Current NDC, Legacy NDC, 2 package rows 20240411_519a44e3-8a93-456c-b71c-894513810d45.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 0641-6137-01 00641613701 10 mL in 1 VIAL 10 ml Historical 0641-6137-10 00641613710 10 VIAL in 1 CARTON (0641-6137-10) / 10 mL in 1 VIAL (0641-6137-01) 10 vial 2007-08-06 0000-00-00 No No Current