phenytoin sodium

Product NDC
62756-299
11-digit product format
627560299
Labeler code
62756
Product ID
62756-299_c89dfc75-606c-4a4e-9d2b-d907b492a837
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenytoin sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040731
Marketing category
ANDA
Marketing start
2008-06-30
Substance
PHENYTOIN SODIUM
Active strength
200 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040731-001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-30
A040731-002EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-30

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 UTC2026-02A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORAL2008-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORAL2008-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040731-001EXTENDED PHENYTOIN SODIUM200MG EXTENDEDCAPSULE / ORALAB2008-06-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A040731-002EXTENDED PHENYTOIN SODIUM300MG EXTENDEDCAPSULE / ORALAB2008-06-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040731-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040731-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040731-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040731-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040731-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040731-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040731-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040731-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040731-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040731-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040731-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040731-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040731-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040731-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040731-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040731-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040731-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040731-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040731-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040731-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040731-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040731-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040731-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040731-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040731-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040731-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040731-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040731-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040731-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040731-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040731-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040731-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040731-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040731-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040731-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040731-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040731-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040731-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040731-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040731-002AB1ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4182431BJHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855861Internal RxNorm lookup
855873Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c40f66cc-6f4a-4b29-84ba-d265e4848735Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
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
62756-299-08phenytoin sodium100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1007
62756-299-13phenytoin sodium500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5007
62756-299-83phenytoin sodium30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
62756-299-88phenytoin sodium100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-299-83EA - Each62756-2998fa6b28f-4f88-46aa-a47c-62ca035b3dfb12012-07-24
62756-299-88EA - Each62756-299c5108fe0-f2e9-4f8a-a7bc-6e7f4ebd014912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
GELATININACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
LACTITOL MONOHYDRATEINACTIVE INGREDIENTUH2K6W1Y64PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
SHELLACINACTIVE INGREDIENT46N107B71OPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-299PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 4 package rows20221228_c40f66cc-6f4a-4b29-84ba-d265e4848735.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
phenytoin sodiumPHENYTOIN SODIUMSun Pharmaceutical Industries, Inc.c40f66cc-6f4a-4b29-84ba-d265e48487352022-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040731
application number: ANDA040731
ndc (product): 62756-299

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855861phenytoin sodium 200 MG Extended Release Oral CapsulePSNc40f66cc-6f4a-4b29-84ba-d265e48487357
855873phenytoin sodium 300 MG Extended Release Oral CapsulePSNc40f66cc-6f4a-4b29-84ba-d265e48487357
855861phenytoin sodium 200 MG Extended Release Oral CapsuleSCDc40f66cc-6f4a-4b29-84ba-d265e48487357
855873phenytoin sodium 300 MG Extended Release Oral CapsuleSCDc40f66cc-6f4a-4b29-84ba-d265e48487357
855861DPH sodium 200 MG Extended Release Oral CapsuleSYc40f66cc-6f4a-4b29-84ba-d265e48487357
855873DPH sodium 300 MG Extended Release Oral CapsuleSYc40f66cc-6f4a-4b29-84ba-d265e48487357

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-299-0862756029908100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-08) 2008-06-300000-00-00NoNoCurrent
62756-299-1362756029913500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-13) 2008-06-300000-00-00NoNoCurrent
62756-299-836275602998330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-83) 2008-06-300000-00-00NoNoCurrent
62756-299-8862756029988100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-88) 2008-06-300000-00-00NoNoCurrent