Home NDC 70121-1381 Fosphenytoin Sodium
Product NDC 70121-1381
11-digit product format 701211381
Labeler code 70121
Product ID 70121-1381_6a6abb75-fca4-400c-9ecb-073802e0cb7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosphenytoin
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA078476
Marketing category ANDA
Marketing start 2016-08-11
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1381 FOSPHENYTOIN SODIUM (FOSPHENYTOIN) INJECTION [AMNEAL PHARMACEUTICALS LLC] 20 Legacy NDC 20240806_39b58213-b9e2-4847-9010-99e187c1b778.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70121-1381-5 70121138105 25 VIAL in 1 CARTON (70121-1381-5) > 2 mL in 1 VIAL (70121-1381-1) 25 vial 2016-08-11 0000-00-00 No No Current