Phenytoin

Product NDC
59762-0531
11-digit product format
597620531
Labeler code
59762
Product ID
59762-0531_212141a3-fffd-49e0-96d5-57cc921a99d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA008762
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-04-22
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

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N008762-001DILANTIN-125PHENYTOIN125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982
N008762-002DILANTIN-30PHENYTOIN30MG/5MLSUSPENSION / ORALApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N008762-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N008762-001DILANTIN-125125MG/5MLSUSPENSION / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N008762-002DILANTIN-3030MG/5MLSUSPENSION / ORALApproved before 1982782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N008762-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008762-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N008762-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008762-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008762-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008762-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008762-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N008762-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N008762-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N008762-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N008762-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N008762-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N008762-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N008762-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N008762-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N008762-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N008762-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N008762-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N008762-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N008762-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N008762-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N008762-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N008762-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N008762-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N008762-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N008762-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N008762-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N008762-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N008762-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N008762-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N008762-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N008762-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N008762-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N008762-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N008762-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N008762-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N008762-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N008762-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N008762-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N008762-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN125 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6158TKW0C5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1313112Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
37943ec1-a8d2-42df-967e-6f96f84c017bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0531-2Phenytoin1 in 1 CARTONSUSPENSION131
59762-0531-2Phenytoin237 mL in 1 BOTTLE, PLASTICSUSPENSION23731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0531-1ML - Milliliter59762-05316bc19a70-2c0d-437c-9ca1-28dd3d03b6e612013-02-13
59762-0531-2ML - Milliliter59762-0531d79c9764-a7ae-4f3d-923b-76e8b8cf367812020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOINACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [GREENSTONE LLC]8
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [GREENSTONE LLC]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SUSPENSION [GREENSTONE LLC]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [GREENSTONE LLC]8
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [GREENSTONE LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [GREENSTONE LLC]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPHENYTOIN SUSPENSION [GREENSTONE LLC]8
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [GREENSTONE LLC]8
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XPHENYTOIN SUSPENSION [GREENSTONE LLC]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [GREENSTONE LLC]8
SUCROSEINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [GREENSTONE LLC]8
VANILLININACTIVE INGREDIENTCHI530446XPHENYTOIN SUSPENSION [GREENSTONE LLC]8
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [GREENSTONE LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0531PHENYTOIN SUSPENSION [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 2 package rows20250503_37943ec1-a8d2-42df-967e-6f96f84c017b.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenytoinPHENYTOINMylan Pharmaceuticals Inc.37943ec1-a8d2-42df-967e-6f96f84c017b2024-12-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 008762
application number: NDA008762
ndc (product): 59762-0531
Dilantin-125PHENYTOINViatris Specialty LLCf339f9e4-b289-4efe-82b9-46c57d1dc2772023-02-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 008762
application number: NDA008762

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSN37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112phenytoin 25 MG/ML Oral SuspensionSCD37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112DPH 25 MG/ML Oral SuspensionSY37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112phenytoin 100 MG per 4 ML Oral SuspensionSY37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112phenytoin 125 MG per 5 ML Oral SuspensionSY37943ec1-a8d2-42df-967e-6f96f84c017b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0531-2597620531021 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC2020-04-220000-00-00NoNoCurrent