Phenytoin Sodium

Product NDC: 64725-4111
11-digit product format: 647254111
Labeler code: 64725
Product ID: 64725-4111_cb714702-6d2b-4987-8045-3586baf12337
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA040684
Marketing category: ANDA
Marketing start: 2006-09-05
Marketing end: 0000-00-00
Substance: PHENYTOIN SODIUM
Active strength: 100 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	64725-4111		I	Inactivated by FDA		2026-08-11
excluded package	package	64725-4111	64725-4111-1	I	Inactivated by FDA		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 · 44 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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`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	64725-4111-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-4111-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-4111-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-4111-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-4111-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-4111-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-4111-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-4111-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-4111-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-4111-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-4111-1	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040684-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB		2006-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040684-001	AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040684-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040684-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040684-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040684-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040684-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040684-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040684-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040684-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040684-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040684-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040684-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040684-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040684-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040684-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040684-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040684-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040684-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040684-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040684-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040684-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040684-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040684-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040684-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040684-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040684-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040684-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040684-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040684-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040684-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040684-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040684-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040684-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040684-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040684-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040684-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040684-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040684-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040684-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040684-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040684-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be8c0c29-be12-4cae-8e3b-1c71ed6b952c	Product name	2	20250626
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
e3d31abf-5149-4e77-89a8-0dc73ec106f9	Product name	1	20210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb	Product name	2	20200303
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-4111-1	2019-11-27	C162847	48780-1	9855e2a2-3a32-60a7-e053-dbdaa90a05bd	Extended Phenytoin Sodium Capsules USP, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-4111-1	Phenytoin Sodium	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenytoin Sodium	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
Phenytoin	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-4111	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20140901_6bdcf521-e68e-4849-bfe2-3d46f038a364.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytoin Sodium	PHENYTOIN SODIUM	A-S Medication Solutions	ef4e97a7-cd18-47a9-a016-2eca5481a87e	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	REMEDYREPACK INC.	e33ce05d-9c60-4ede-8b13-e8c41a3de25d	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Coupler LLC	51b660c3-7d88-77b2-e063-6294a90a0286	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Golden State Medical Supply, Inc.	36262a4c-33f1-40a5-e063-6394a90ad36a	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	REMEDYREPACK INC.	844a16db-17d5-44da-819d-54f3e19cfec2	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Sun Pharmaceutical Industries, Inc.	601f7353-225d-4a5d-9810-3869c2c21874	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	AvPAK	4c2542b8-ac54-e85d-e063-6294a90a759b	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Proficient Rx LP	f4353734-29b0-4027-824d-2fc97f778c67	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Major Pharmaceuticals	46d5c0d1-a97b-46d9-8cf4-994780673337	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	3bc82d23-3950-f181-e063-6394a90ad565	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	29b8d0a2-a96e-46a5-e063-6394a90a7113	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	Bryant Ranch Prepack	6b4c2885-eae0-4c88-ada3-62a699df1dbb	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684
Phenytoin Sodium	PHENYTOIN SODIUM	A-S Medication Solutions	d4459837-da26-4c97-8587-32eb1f682d58	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040684 application number: ANDA040684

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	6bdcf521-e68e-4849-bfe2-3d46f038a364	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	6bdcf521-e68e-4849-bfe2-3d46f038a364	2
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	6bdcf521-e68e-4849-bfe2-3d46f038a364	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-4111-1	64725411101	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Extended Phenytoin Sodium Capsules USP, 100 mg	TYA Pharmaceuticals	2014-06-17	HUMAN PRESCRIPTION DRUG LABEL	2