Phenytoin Sodium

Product NDC: 67046-0585
11-digit product format: 670460585
Labeler code: 67046
Product ID: 67046-0585_51b655cf-3f3d-bc96-e063-6394a90a6954
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA040684
Marketing category: ANDA
Marketing start: 2026-05-13
Substance: PHENYTOIN SODIUM
Active strength: 100 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: 2027-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phenytoin Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYTOIN SODIUM	100 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855671	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
51b660c3-7d88-77b2-e063-6294a90a0286	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-0585-3	Phenytoin Sodium	30 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	30		1

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 ndc (product): 67046-0585
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	51b660c3-7d88-77b2-e063-6294a90a0286	1
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	51b660c3-7d88-77b2-e063-6294a90a0286	1
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	51b660c3-7d88-77b2-e063-6294a90a0286	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-0585-3	67046058503	30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-0585-3)	2026-05-13	No	No	Current