Dilantin-125

Product NDC: 58151-115
11-digit product format: 581510115
Labeler code: 58151
Product ID: 58151-115_f339f9e4-b289-4efe-82b9-46c57d1dc277
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA008762
Marketing category: NDA
Marketing start: 2024-04-19
Substance: PHENYTOIN
Active strength: 125 mg/5mL
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
N008762-001	DILANTIN-125	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982
N008762-002	DILANTIN-30	PHENYTOIN	30MG/5ML	SUSPENSION / ORAL		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
N008762-001	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 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	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008762-001	DILANTIN-125	125MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008762-002	DILANTIN-30	30MG/5ML	SUSPENSION / ORAL		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	N008762-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008762-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008762-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008762-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008762-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008762-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008762-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008762-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008762-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008762-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008762-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008762-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008762-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008762-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008762-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008762-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008762-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008762-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008762-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008762-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008762-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008762-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008762-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008762-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008762-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008762-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008762-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008762-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008762-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008762-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008762-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008762-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008762-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008762-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008762-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008762-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008762-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008762-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008762-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N008762-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dilantin-125
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYTOIN	125 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6158TKW0C5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1313112	Internal RxNorm lookup
1313884	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
f339f9e4-b289-4efe-82b9-46c57d1dc277	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	Strength	SPL version
58151-115-35	Dilantin-125	237 mL in 1 BOTTLE, PLASTIC	SUSPENSION	237		1
58151-115-35	Dilantin-125	1 in 1 CARTON	SUSPENSION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58151-115-35	ML - Milliliter	58151-115	3206f32b-0464-4bb6-bc56-48a51c819d67	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58151-115	DILANTIN-125 (PHENYTOIN) SUSPENSION [VIATRIS SPECIALTY LLC]	1	Current NDC, 2 package rows	20240420_f339f9e4-b289-4efe-82b9-46c57d1dc277.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
Phenytoin	PHENYTOIN	Mylan Pharmaceuticals Inc.	37943ec1-a8d2-42df-967e-6f96f84c017b	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008762 application number: NDA008762
Dilantin-125	PHENYTOIN	Viatris Specialty LLC	f339f9e4-b289-4efe-82b9-46c57d1dc277	2023-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008762 application number: NDA008762 ndc (product): 58151-115

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6158TKW0C5	PHENYTOIN	57-41-0	PHENYTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1313884	Dilantin-125, 125 MG in 5 mL Oral Suspension	PSN	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313112	phenytoin 125 MG in 5 mL Oral Suspension	PSN	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313884	phenytoin 25 MG/ML Oral Suspension [Dilantin]	SBD	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313112	phenytoin 25 MG/ML Oral Suspension	SCD	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313884	Dilantin 125 MG per 5 ML Oral Suspension	SY	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313884	Dilantin 25 MG/ML Oral Suspension	SY	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313884	Dilantin-125 Oral Suspension	SY	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313112	DPH 25 MG/ML Oral Suspension	SY	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313884	DPH 25 MG/ML Oral Suspension [Dilantin]	SY	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313112	phenytoin 100 MG per 4 ML Oral Suspension	SY	f339f9e4-b289-4efe-82b9-46c57d1dc277	1
1313112	phenytoin 125 MG per 5 ML Oral Suspension	SY	f339f9e4-b289-4efe-82b9-46c57d1dc277	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
58151-115-35	58151011535	1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC	2024-04-19	No	No	Current