Phenytek

Product NDC: 67046-1486
11-digit product format: 670461486
Labeler code: 67046
Product ID: 67046-1486_2cdc1905-8ef2-1275-e063-6394a90a2ab7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: extended phenytoin sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA040298
Marketing category: ANDA
Marketing start: 2025-01-29
Substance: PHENYTOIN SODIUM
Active strength: 200 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	200 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855861	Internal RxNorm lookup
855863	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
2cdc1905-8f45-1275-e063-6394a90a2ab7	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
67046-1486-3	Phenytek	30 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1486	PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [COUPLER LLC]	1	Current NDC, 1 package rows	20250130_2cdc1905-8f45-1275-e063-6394a90a2ab7.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 ndc (product): 67046-1486
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
855863	Phenytek 200 MG Extended Release Oral Capsule	PSN	2cdc1905-8f45-1275-e063-6394a90a2ab7	1
855861	phenytoin sodium 200 MG Extended Release Oral Capsule	PSN	2cdc1905-8f45-1275-e063-6394a90a2ab7	1
855863	phenytoin sodium 200 MG Extended Release Oral Capsule [Phenytek]	SBD	2cdc1905-8f45-1275-e063-6394a90a2ab7	1
855861	phenytoin sodium 200 MG Extended Release Oral Capsule	SCD	2cdc1905-8f45-1275-e063-6394a90a2ab7	1
855861	DPH sodium 200 MG Extended Release Oral Capsule	SY	2cdc1905-8f45-1275-e063-6394a90a2ab7	1
855863	DPH sodium 200 MG Extended Release Oral Capsule [Phenytek]	SY	2cdc1905-8f45-1275-e063-6394a90a2ab7	1
855863	Phenytek 200 MG Extended Release Oral Capsule	SY	2cdc1905-8f45-1275-e063-6394a90a2ab7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1486-3	67046148603	30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3)	2025-01-29	No	No	Current