Phenytek

Product NDC: 0378-3750
11-digit product format: 003783750
Labeler code: 0378
Product ID: 0378-3750_a532ea94-0186-4554-969c-66ff80f95c94
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: 2001-12-10
Substance: PHENYTOIN SODIUM
Active strength: 300 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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phenytek
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYTOIN SODIUM	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4182431BJH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855861	Internal RxNorm lookup
855863	Internal RxNorm lookup
855873	Internal RxNorm lookup
855875	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
0f94c791-8b07-4b41-927e-c9f28bec5f60	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-3750-01	Phenytek	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		21
0378-3750-93	Phenytek	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3750-01	EA - Each	0378-3750	d4822c25-d0f2-4146-82fc-7819a2735bfb	1	2012-07-24
0378-3750-93	EA - Each	0378-3750	91c265a7-9190-4ef0-bc4e-0b2a300a516f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-3750	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	21	Current NDC, Legacy NDC, 2 package rows	20241113_0f94c791-8b07-4b41-927e-c9f28bec5f60.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 · 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 ndc (product): 0378-3750

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
855863	Phenytek 200 MG Extended Release Oral Capsule	PSN	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855875	Phenytek 300 MG Extended Release Oral Capsule	PSN	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855861	phenytoin sodium 200 MG Extended Release Oral Capsule	PSN	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855873	phenytoin sodium 300 MG Extended Release Oral Capsule	PSN	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855863	phenytoin sodium 200 MG Extended Release Oral Capsule [Phenytek]	SBD	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855875	phenytoin sodium 300 MG Extended Release Oral Capsule [Phenytek]	SBD	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855861	phenytoin sodium 200 MG Extended Release Oral Capsule	SCD	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855873	phenytoin sodium 300 MG Extended Release Oral Capsule	SCD	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855861	DPH sodium 200 MG Extended Release Oral Capsule	SY	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855863	DPH sodium 200 MG Extended Release Oral Capsule [Phenytek]	SY	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855873	DPH sodium 300 MG Extended Release Oral Capsule	SY	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855875	DPH sodium 300 MG Extended Release Oral Capsule [Phenytek]	SY	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855863	Phenytek 200 MG Extended Release Oral Capsule	SY	0f94c791-8b07-4b41-927e-c9f28bec5f60	21
855875	Phenytek 300 MG Extended Release Oral Capsule	SY	0f94c791-8b07-4b41-927e-c9f28bec5f60	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3750-01	00378375001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01)	2001-12-10	2030-01-31	No	No	Current
0378-3750-93	00378375093	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)	2001-12-10	2030-01-31	No	No	Current