Phenytoin Sodium

Product NDC: 51079-905
11-digit product format: 510790905
Labeler code: 51079
Product ID: 51079-905_e16f10ad-cde9-591e-e053-2995a90a2b6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenytoin sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA040298
Marketing category: ANDA
Marketing start: 1999-05-01
Marketing end: 2023-02-28
Substance: PHENYTOIN SODIUM
Active strength: 100 mg/1
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: 0000-00-00
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	51079-905		D	Discontinued by firm		2026-10-05
excluded package	package	51079-905	51079-905-20	D	Discontinued by firm		2026-10-05

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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`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	51079-905-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A040298-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		1998-12-28
A040298-002	PHENYTEK	PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2001-12-06
A040298-003	PHENYTEK	PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	RS	2001-12-06

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 4 · 129 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
2026-09-14 22:38:34	2026-08	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL			2001-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL		RS	2001-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL	AB		2001-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL	AB	RS	2001-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL	AB		2001-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL	AB	RS	2001-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL	AB		2001-12-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL	AB	RS	2001-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL	AB		2001-12-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL	AB	RS	2001-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040298-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040298-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040298-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040298-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040298-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040298-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040298-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040298-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040298-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040298-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040298-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040298-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040298-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040298-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040298-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040298-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040298-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040298-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040298-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040298-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040298-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040298-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040298-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040298-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040298-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040298-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040298-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040298-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040298-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040298-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040298-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040298-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040298-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040298-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040298-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040298-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040298-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040298-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040298-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040298-002	AB	1	`8869cabd3fbd…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-905-01	EA - Each	51079-905	9f2e4935-2fd5-4b5b-979e-c59f1d2c0d0a	1	2013-02-13
51079-905-17	EA - Each	51079-905	0542110f-30ae-4fe4-86df-d155eaa3f4ac	1	2013-02-13
51079-905-19	EA - Each	51079-905	672787c6-8af5-4dde-b623-1c109f18ee10	1	2013-02-13
51079-905-20	EA - Each	51079-905	810e26b0-89ec-4ebf-8f59-f9c7b6faee73	1	2013-02-13
51079-905-30	EA - Each	51079-905	ec052ee2-e856-4492-8e13-05c9ac74f191	1	2015-12-02
51079-905-56	EA - Each	51079-905	800d5c7c-bb3a-4041-a145-f4a704998dbe	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]	5

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytek	EXTENDED PHENYTOIN SODIUM	Coupler LLC	2cdc1905-8f45-1275-e063-6394a90a2ab7	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040298 application number: ANDA040298
Phenytek	EXTENDED PHENYTOIN SODIUM	Mylan Pharmaceuticals Inc.	0f94c791-8b07-4b41-927e-c9f28bec5f60	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040298 application number: ANDA040298

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4182431BJH	PHENYTOIN SODIUM	630-93-3	PHENYTOIN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-905-20	51079090520	100 BLISTER PACK in 1 CARTON (51079-905-20) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (51079-905-01)	100 blister pack	1999-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenytoin Sodium	Mylan Institutional Inc.	2022-06-14	HUMAN PRESCRIPTION DRUG LABEL	13
Phenytoin Sodium - Cardinal Health	Cardinal Health	2019-04-23	HUMAN PRESCRIPTION DRUG LABEL	9