Fosphenytoin Sodium

Product NDC: 70121-1390
11-digit product format: 701211390
Labeler code: 70121
Product ID: 70121-1390_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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70121-1390		D	Discontinued by firm		2026-08-17
excluded package	package	70121-1390	70121-1390-7	D	Discontinued by firm		2026-08-17

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078476-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078476-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078476-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078476-001	AP	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70121-1390-1	ML - Milliliter	70121-1390	7c66a930-95e1-41a1-92e7-fd483c94fbd3	1	2016-09-02
70121-1390-7	ML - Milliliter	70121-1390	cce07a7b-ae89-4922-a808-d67b958970e7	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70121-1390	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosphenytoin Sodium	FOSPHENYTOIN SODIUM	Amneal Pharmaceuticals LLC	87ff8a91-5b37-401c-b75c-dc6efd348761	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078476 application number: ANDA078476

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7VLR55452Z	FOSPHENYTOIN SODIUM	92134-98-0	FOSPHENYTOIN SODIUM
B4SF212641	FOSPHENYTOIN	93390-81-9	Fosphenytoin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70121-1390-7	70121139007	10 VIAL in 1 CARTON (70121-1390-7) > 10 mL in 1 VIAL (70121-1390-1)	10 vial	2016-08-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosphenytoin Sodium	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2022-07-03	HUMAN PRESCRIPTION DRUG LABEL	20