Dilantin

Product NDC: 43353-131
11-digit product format: 433530131
Labeler code: 43353
Product ID: 43353-131_0bedfead-19aa-4149-ba58-4d0f189267b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: ANDA084349
Marketing category: ANDA
Marketing start: 1976-08-27
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: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-131		I	Inactivated by FDA	2026-08-11
excluded package	package	43353-131	43353-131-60	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-131	43353-131-70	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-131	43353-131-75	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-131	43353-131-92	I	Inactivated by FDA	2026-08-11
excluded package	package	43353-131	43353-131-94	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 3 · 126 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	43353-131-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-131-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-131-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-131-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-131-70	`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	43353-131-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-131-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-131-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-131-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-131-70	`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	43353-131-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-131-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-131-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-131-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-131-70	`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	43353-131-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-131-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-131-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-131-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-131-70	`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	43353-131-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-131-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-131-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-131-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-131-70	`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	43353-131-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-131-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-131-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-131-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-131-70	`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	43353-131-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-131-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-131-75	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-131-94	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-131-70	`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	43353-131-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-131-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-131-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-131-94	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-131-70	`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	43353-131-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-131-92	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-131-75	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-131-94	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-131-70	`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	43353-131-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-131-92	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-131-75	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-131-94	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-131-70	`ad56d346431e…`	`cc804d4bbf1e…`

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, Related label table
NDC	Related label
43353-131-60	Dilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-70	Dilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-75	Dilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-92	Dilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-94	Dilantin ® (extended phenytoin sodium capsules, USP) 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-131-60	Dilantin	90 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	90	1
43353-131-70	Dilantin	120 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	120	1
43353-131-75	Dilantin	150 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	150	1
43353-131-92	Dilantin	270 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	270	1
43353-131-94	Dilantin	360 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	360	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-131-60	EA - Each	43353-131	592a81a7-2c35-43b3-beef-645d6dbb52b2	1	2014-08-01
43353-131-70	EA - Each	43353-131	f822a8eb-851a-40d1-8b92-43c22358de98	1	2013-03-03
43353-131-75	EA - Each	43353-131	573aad27-3d74-442c-9128-ddc5e683e5f8	1	2013-03-03
43353-131-92	EA - Each	43353-131	51a0cc1f-6241-4125-ab1c-ff2d3cc72e0c	1	2013-03-03
43353-131-94	EA - Each	43353-131	ca619f59-c4fa-415c-8a96-20f67d54cb7e	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenytoin Sodium	ACTIVE INGREDIENT	4182431BJH	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Phenytoin	ACTIVE MOIETY	6158TKW0C5	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
D&C red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-131	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 5 package rows	20120815_ecab970d-83e9-4aad-92de-dbb73d7a151f.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855673	Dilantin 100 MG Extended Release Oral Capsule	PSN	ecab970d-83e9-4aad-92de-dbb73d7a151f	1
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	ecab970d-83e9-4aad-92de-dbb73d7a151f	1
855673	phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]	SBD	ecab970d-83e9-4aad-92de-dbb73d7a151f	1
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	ecab970d-83e9-4aad-92de-dbb73d7a151f	1
855673	Dilantin 100 MG Extended Release Oral Capsule	SY	ecab970d-83e9-4aad-92de-dbb73d7a151f	1
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	ecab970d-83e9-4aad-92de-dbb73d7a151f	1
855673	DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]	SY	ecab970d-83e9-4aad-92de-dbb73d7a151f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-131-60	43353013160	90 in 1 BOTTLE, PLASTIC	Historical
43353-131-70	43353013170	120 in 1 BOTTLE, PLASTIC	Historical
43353-131-75	43353013175	150 in 1 BOTTLE, PLASTIC	Historical
43353-131-92	43353013192	270 in 1 BOTTLE, PLASTIC	Historical
43353-131-94	43353013194	360 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dilantin ® (extended phenytoin sodium capsules, USP) 100 mg	Aphena Pharma Solutions - Tennessee, Inc.	2012-06-20	HUMAN PRESCRIPTION DRUG LABEL	1