Phenytek

Product NDC: 67046-1486
Requested package NDC: 67046-1486-3
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 67046-1486-3 ndc (product): 67046-1486 ndc11 (package): 67046148603
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

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

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