Fosphenytoin

Product NDC: 63323-403
11-digit product format: 633230403
Labeler code: 63323
Product ID: 63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FOSPHENYTOIN SODIUM
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA078052
Marketing category: ANDA
Marketing start: 2009-12-14
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

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	63323-403		D	Discontinued by firm		2026-08-17
excluded package	package	63323-403	63323-403-09	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-403-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-403-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-403-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-403-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-403-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-403-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-403-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63323-403-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63323-403-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63323-403-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63323-403-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63323-403-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078052-001	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
A078052-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078052-001	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	A078052-001	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	A078052-001	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	A078052-001	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	A078052-001	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	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078052-001	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	A078052-001	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	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078052-001	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	A078052-001	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	A078052-001	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	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078052-001	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	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078052-001	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE / INJECTION	AP	2007-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078052-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078052-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078052-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078052-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078052-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078052-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078052-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078052-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078052-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078052-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078052-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078052-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078052-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078052-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078052-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078052-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078052-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078052-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078052-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078052-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078052-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078052-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078052-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078052-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078052-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078052-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078052-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078052-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078052-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078052-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078052-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078052-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078052-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078052-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078052-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078052-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078052-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078052-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078052-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078052-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078052-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fosphenytoin
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
b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	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	SPL version
63323-403-01	Fosphenytoin	2 mL in 1 VIAL	INJECTION, SOLUTION	2	14
63323-403-02	Fosphenytoin	25 in 1 TRAY	INJECTION, SOLUTION	25	14
63323-403-04	Fosphenytoin	10 mL in 1 VIAL	INJECTION, SOLUTION	10	14
63323-403-10	Fosphenytoin	10 in 1 TRAY	INJECTION, SOLUTION	10	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-403-01	ML - Milliliter	63323-403	1e2e3f93-b845-42e3-819d-5d1d86109c8f	1	2018-08-13
63323-403-02	ML - Milliliter	63323-403	565eaf95-6a7e-44da-950c-687bfa783865	1	2012-07-24
63323-403-04	ML - Milliliter	63323-403	5b6a304c-1805-4fca-a4eb-ab6cfe94563a	1	2018-08-13
63323-403-10	ML - Milliliter	63323-403	f39ee679-eb9c-426d-96bf-f1203af01838	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FOSPHENYTOIN SODIUM	ACTIVE INGREDIENT	7VLR55452Z	FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-403	FOSPHENYTOIN (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	14	Current NDC, Legacy NDC, 4 package rows	20230519_b60c9c82-e5c7-4e05-98c7-5bbba4af04b2.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	FOSPHENYTOIN SODIUM	Fresenius Kabi USA, LLC	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	2023-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078052 application number: ANDA078052 ndc (product): 63323-403

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	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14
1670195	fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML Injection	PSN	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14
1670195	10 ML fosphenytoin sodium 75 MG/ML Injection	SCD	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14
1670200	2 ML fosphenytoin sodium 75 MG/ML Injection	SCD	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14
1670200	fosphenytoin sodium 100 MG PE per 2 ML Injection	SY	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14
1670195	fosphenytoin sodium 500 MG PE per 10 ML Injection	SY	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14
1670200	fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) Injection	SY	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14
1670195	fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) Injection	SY	b60c9c82-e5c7-4e05-98c7-5bbba4af04b2	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-403-01	63323040301	2 mL in 1 VIAL	2 ml					Historical
63323-403-02	63323040302	25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01)	25 vial	2009-12-14	0000-00-00	No	No	Current
63323-403-04	63323040304	10 mL in 1 VIAL	10 ml					Historical
63323-403-10	63323040310	10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04)	10 vial	2009-12-14	0000-00-00	No	No	Current