Phenytoin Sodium

Product NDC: 0378-1560
Requested package NDC: 0378-1560-01
11-digit product format: 003781560
Labeler code: 0378
Product ID: 0378-1560_1d448420-390f-46ad-ad5a-3145e77be8ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenytoin sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA040298
Marketing category: ANDA
Marketing start: 1999-01-05
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-1560	0378-1560-01	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL	AB		2001-12-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL	AB	RS	2001-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040298-002	PHENYTEK	200MG EXTENDED	CAPSULE / ORAL	AB		2001-12-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040298-003	PHENYTEK	300MG EXTENDED	CAPSULE / ORAL	AB	RS	2001-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040298-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			1998-12-28	`8072bd15b7f6…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be8c0c29-be12-4cae-8e3b-1c71ed6b952c	Product name	2	20250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e3d31abf-5149-4e77-89a8-0dc73ec106f9	Product name	1	20210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb	Product name	2	20200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1560-01	EA - Each	0378-1560	ba2261b3-2fdb-483a-9b17-f27c10f8fd87	1	2012-07-24
0378-1560-10	EA - Each	0378-1560	134b8f38-b7b8-4f66-b23f-41d22c7a9705	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
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
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 [MYLAN INSTITUTIONAL INC.]	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
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	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 [MYLAN INSTITUTIONAL INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	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 [MYLAN INSTITUTIONAL INC.]	5
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	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
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	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
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	5
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN ER (PHENYTOIN SODIUM) CAPSULE [STAT RX USA LLC]	1
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN ER (PHENYTOIN SODIUM) CAPSULE [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	404bb4d0-dade-4fb7-a85d-d5233d49fd98	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	cc521263-7ddc-4a79-a3ca-466848e32c23	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	404bb4d0-dade-4fb7-a85d-d5233d49fd98	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	cc521263-7ddc-4a79-a3ca-466848e32c23	2
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	404bb4d0-dade-4fb7-a85d-d5233d49fd98	2
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	cc521263-7ddc-4a79-a3ca-466848e32c23	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	9367137e-200c-48c6-9634-135e1faeb101	1
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	9367137e-200c-48c6-9634-135e1faeb101	1
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	9367137e-200c-48c6-9634-135e1faeb101	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1560-01	00378156001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-01)	1999-01-05	2023-02-28	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	Mylan Pharmaceuticals Inc.	2021-11-15	HUMAN PRESCRIPTION DRUG LABEL	15
Phenytoin Sodium - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
Phenytoin Sodium - Bryant Ranch Prepack	Bryant Ranch Prepack	2012-10-23	HUMAN PRESCRIPTION DRUG LABEL	1000
Extended Phenytoin Sodium Caps	NCS HealthCare of KY, Inc dba Vangard Labs	2011-06-15	HUMAN PRESCRIPTION DRUG LABEL	1
Phenytoin Sodium - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-08-12	HUMAN PRESCRIPTION DRUG LABEL	2
PHENYTOIN ER - STAT RX USA LLC	STAT RX USA LLC	2010-02-19	HUMAN PRESCRIPTION DRUG LABEL	1