DILANTIN

Product NDC: 58151-110
11-digit product format: 581510110
Labeler code: 58151
Product ID: 58151-110_872f23a8-e6a3-4038-922d-0c26fc81d8b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Extended Phenytoin Sodium
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Viatris Specialty LLC
Application: ANDA084349
Marketing category: ANDA
Marketing start: 2024-12-06
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: 2026-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: DILANTIN
Listing expiration: 2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855671	Internal RxNorm lookup
855673	Internal RxNorm lookup
855869	Internal RxNorm lookup
855871	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
86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	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
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	SPL version
58151-110-01	DILANTIN	100 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	100	3
58151-110-10	DILANTIN	1000 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	1000	3
58151-110-32	DILANTIN	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1	3
58151-110-88	DILANTIN	100 in 1 CARTON	CAPSULE, EXTENDED RELEASE	100	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58151-110-01	EA - Each	58151-110	e83a5537-58db-4591-af60-6df4cece3509	1	2025-01-14
58151-110-10	EA - Each	58151-110	dcf7325e-b6cd-441e-b235-24b96615a893	1	2025-05-14
58151-110-32	EA - Each	58151-110	553a82f4-1b61-4d8a-ba26-1a84888dc41d	1	2025-01-14
58151-110-88	EA - Each	58151-110	4ecdc811-e103-4e49-ab73-2a6be323f8a4	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58151-110	DILANTIN (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]	3	Current NDC, 4 package rows	20250410_86dd27d1-9cee-48ae-b55d-e2d2f7dbc593.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 ndc (product): 58151-110

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	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855871	Dilantin 30 MG Extended Release Oral Capsule	PSN	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	PSN	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855673	phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]	SBD	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855871	phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]	SBD	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	SCD	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855673	Dilantin 100 MG Extended Release Oral Capsule	SY	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855871	Dilantin 30 MG Extended Release Oral Capsule	SY	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855673	DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]	SY	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855869	DPH sodium 30 MG Extended Release Oral Capsule	SY	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3
855871	DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]	SY	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58151-110-01	58151011001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01)		2024-12-06	No	No	Current
58151-110-10	58151011010	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10)		2025-04-09	No	No	Current
58151-110-32	58151011032	1 in 1 BLISTER PACK					Historical
58151-110-88	58151011088	100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)	100 blister pack	2024-12-06	No	No	Current