Phenytoin Sodium

Product NDC: 58118-4111
Requested package NDC: 58118-4111-8
11-digit product format: 581184111
Labeler code: 58118
Product ID: 58118-4111_b02680e2-2284-73b9-e053-2a95a90aa899
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA040684
Marketing category: ANDA
Marketing start: 2019-03-07
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: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58118-4111	58118-4111-8	D	Discontinued by firm		2026-08-17

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	A040684-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-09-05	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040684-001	AB	1	`caaa826d4ba7…`
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58118-4111-8	2024-01-30	C162847	48780-1	1030e365-1cc2-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-4111	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]	3	Legacy NDC	20200926_1884b719-ca9e-42a1-bf5c-38f2de8d66ff.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58118-4111-8	58118411108	30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58118-4111-8)	2019-03-07	0000-00-00	No	No	Current