Fosphenytoin sodium

Product NDC: 68083-460
11-digit product format: 680830460
Labeler code: 68083
Product ID: 68083-460_00f57b3c-3819-440e-a928-eeec0fee27aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosphenytoin sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA214926
Marketing category: ANDA
Marketing start: 2023-10-13
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 43.

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214926-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2023-10-13	`84e616aacf4f…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214926-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214926-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214926-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214926-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214926-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214926-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214926-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214926-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214926-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214926-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214926-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214926-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214926-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214926-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214926-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214926-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214926-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214926-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214926-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214926-001	AP	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214926-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
49b08648-6a83-42c7-ae7b-80c29f2534fc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
be8c0c29-be12-4cae-8e3b-1c71ed6b952c	Product name	2	20250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9	Product name	1	20210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb	Product name	2	20200303
031bbc61-0564-1f35-2716-aa5c1d139248	Product name	2	20141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70	Product name	1	20140508
eafc3fd3-6834-3129-5bbb-8a9a495691ab	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-460-01	Fosphenytoin sodium	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		6
68083-460-25	Fosphenytoin sodium	25 in 1 CARTON	INJECTION, SOLUTION	25		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-460	FOSPHENYTOIN SODIUM INJECTION, SOLUTION [GLAND PHARMA LIMITED]	6	Current NDC, 2 package rows	20231024_49b08648-6a83-42c7-ae7b-80c29f2534fc.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 · 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
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 ndc (product): 68083-460

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7VLR55452Z	FOSPHENYTOIN SODIUM	92134-98-0	FOSPHENYTOIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1670200	fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML Injection	PSN	49b08648-6a83-42c7-ae7b-80c29f2534fc	6
1670195	fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML Injection	PSN	49b08648-6a83-42c7-ae7b-80c29f2534fc	6
1670195	10 ML fosphenytoin sodium 75 MG/ML Injection	SCD	49b08648-6a83-42c7-ae7b-80c29f2534fc	6
1670200	2 ML fosphenytoin sodium 75 MG/ML Injection	SCD	49b08648-6a83-42c7-ae7b-80c29f2534fc	6
1670200	fosphenytoin sodium 100 MG PE per 2 ML Injection	SY	49b08648-6a83-42c7-ae7b-80c29f2534fc	6
1670195	fosphenytoin sodium 500 MG PE per 10 ML Injection	SY	49b08648-6a83-42c7-ae7b-80c29f2534fc	6
1670200	fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) Injection	SY	49b08648-6a83-42c7-ae7b-80c29f2534fc	6
1670195	fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) Injection	SY	49b08648-6a83-42c7-ae7b-80c29f2534fc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68083-460-01	68083046001	2 mL in 1 VIAL, SINGLE-DOSE	2 ml				Historical
68083-460-25	68083046025	25 VIAL, SINGLE-DOSE in 1 CARTON (68083-460-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-460-01)		2023-10-13	No	No	Current