Phenytoin Sodium

Product NDC
70518-2293
11-digit product format
705182293
Labeler code
70518
Product ID
70518-2293_4ddae581-69c7-01f8-e063-6394a90a835f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040684
Marketing category
ANDA
Marketing start
2019-09-03
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
2027-12-31
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-229370518-2293-0DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040684-001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040684-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053f01610625f2…
2019-09-15 20:21 UTC2019-09A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05cb3db0bc1861…

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 UTC2026-02A040684-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040684-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040684-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040684-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040684-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040684-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040684-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040684-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040684-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040684-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040684-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040684-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040684-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040684-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040684-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040684-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040684-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040684-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040684-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040684-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040684-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040684-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040684-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040684-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040684-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040684-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040684-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040684-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040684-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040684-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040684-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040684-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040684-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040684-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040684-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040684-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040684-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040684-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040684-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040684-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phenytoin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM100 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855671Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
844a16db-17d5-44da-819d-54f3e19cfec2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
70518-2293-0Phenytoin Sodium30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3016
70518-2293-1Phenytoin Sodium100 in 1 BOXCAPSULE, EXTENDED RELEASE10016
70518-2293-2Phenytoin Sodium1 in 1 POUCHCAPSULE, EXTENDED RELEASE116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2293PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 3 package rows20250309_844a16db-17d5-44da-819d-54f3e19cfec2.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenytoin SodiumPHENYTOIN SODIUMA-S Medication Solutionsef4e97a7-cd18-47a9-a016-2eca5481a87e2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.e33ce05d-9c60-4ede-8b13-e8c41a3de25d2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMCoupler LLC51b660c3-7d88-77b2-e063-6294a90a02862026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMGolden State Medical Supply, Inc.36262a4c-33f1-40a5-e063-6394a90ad36a2026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.844a16db-17d5-44da-819d-54f3e19cfec22026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
ndc (product): 70518-2293
Phenytoin SodiumPHENYTOIN SODIUMSun Pharmaceutical Industries, Inc.601f7353-225d-4a5d-9810-3869c2c218742026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMAvPAK4c2542b8-ac54-e85d-e063-6294a90a759b2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMProficient Rx LPf4353734-29b0-4027-824d-2fc97f778c672026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMMajor Pharmaceuticals46d5c0d1-a97b-46d9-8cf4-9947806733372025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMAphena Pharma Solutions - Tennessee, LLC3bc82d23-3950-f181-e063-6394a90ad5652025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMAphena Pharma Solutions - Tennessee, LLC29b8d0a2-a96e-46a5-e063-6394a90a71132024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMBryant Ranch Prepack6b4c2885-eae0-4c88-ada3-62a699df1dbb2024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMA-S Medication Solutionsd4459837-da26-4c97-8587-32eb1f682d582024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN844a16db-17d5-44da-819d-54f3e19cfec216
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD844a16db-17d5-44da-819d-54f3e19cfec216
855671DPH sodium 100 MG Extended Release Oral CapsuleSY844a16db-17d5-44da-819d-54f3e19cfec216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2293-07051822930030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2293-0) 2019-09-030000-00-00NoNoCurrent
70518-2293-170518229301100 POUCH in 1 BOX (70518-2293-1) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2293-2) 100 pouch2021-08-050000-00-00NoNoCurrent
70518-2293-2705182293021 in 1 POUCHHistorical