Dilantin

Product NDC: 70518-0980
Requested package NDC: 70518-0980-1
11-digit product format: 705180980
Labeler code: 70518
Product ID: 70518-0980_dfc204b4-0649-d3ca-e053-2995a90ad220
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA084349
Marketing category: ANDA
Marketing start: 2018-01-22
Marketing end: 0000-00-00
Substance: PHENYTOIN SODIUM
Active strength: 30 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: 2023-12-31
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	70518-0980	70518-0980-1	D	Discontinued by firm		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 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084349-001	DILANTIN	PHENYTOIN SODIUM	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982
A084349-002	DILANTIN	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084349-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`

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	A084349-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084349-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084349-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084349-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084349-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084349-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084349-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084349-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084349-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084349-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084349-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084349-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084349-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084349-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084349-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084349-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084349-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084349-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084349-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084349-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084349-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084349-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084349-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084349-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084349-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084349-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084349-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084349-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084349-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084349-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084349-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084349-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084349-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084349-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084349-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084349-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084349-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084349-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084349-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084349-002	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
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, Related label table
NDC	Effective	Related label
70518-0980-0	2025-11-13	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953
70518-0980-1	2025-11-13	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953
70518-0980-0	2024-01-30	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953
70518-0980-1	2024-01-30	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953
70518-0980-0	2022-06-04	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953
70518-0980-1	2022-06-04	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953
70518-0980-0	2022-01-28	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953
70518-0980-1	2022-01-28	These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (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
70518-0980	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]	5	Legacy NDC	20220604_f1d41925-3be0-42a8-86f8-181569399c5b.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
DILANTIN	EXTENDED PHENYTOIN SODIUM	REMEDYREPACK INC.	db8c69b0-4697-433e-98c7-b0b2d2c52a83	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084349 application number: ANDA084349
DILANTIN	EXTENDED PHENYTOIN SODIUM	Viatris Specialty LLC	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	2023-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084349 application number: ANDA084349

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0980-1	70518098001	100 POUCH in 1 BOX (70518-0980-1) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-0980-2)	100 pouch	2020-01-06	0000-00-00	No	No	Current