Phenytoin Sodium

Product NDC
0615-8020
11-digit product format
006158020
Labeler code
0615
Product ID
0615-8020_57041ea1-a14e-483e-a41b-1bea65bb87ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA040684
Marketing category
ANDA
Marketing start
2006-09-05
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-8020DDiscontinued by firm2026-08-11
excluded packagepackage0615-80200615-8020-30DDiscontinued by firm2026-08-11
excluded packagepackage0615-80200615-8020-39DDiscontinued by firm2026-08-11

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-8020-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-8020-39d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-8020-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-8020-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-8020-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-8020-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-8020-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-8020-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-8020-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-8020-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-8020-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-8020-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-8020-30557ba5c1ecfa…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…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8020PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]16Legacy NDC20240907_04ee6ba3-b086-4f28-9874-5728feebf677.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8020-30006158020306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8020-30) > 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2006-09-050000-00-00NoNoCurrent
0615-8020-390061580203930 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8020-39) 2006-09-050000-00-00NoNoCurrent