Home NDC 62756-432 phenytoin sodium
Product NDC 62756-432
11-digit product format 627560432
Labeler code 62756
Product ID 62756-432_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 300 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040731-001 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 A040731-002 EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL 2008-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL 2008-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040731-001 EXTENDED PHENYTOIN SODIUM 200MG EXTENDED CAPSULE / ORAL AB 2008-06-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040731-002 EXTENDED PHENYTOIN SODIUM 300MG EXTENDED CAPSULE / ORAL AB 2008-06-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base phenytoin sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYTOIN SODIUM 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4182431BJH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855861 Internal RxNorm lookup 855873 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62756-432-08 phenytoin sodium 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 7 62756-432-13 phenytoin sodium 500 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 500 7 62756-432-83 phenytoin sodium 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 7 62756-432-88 phenytoin sodium 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYTOIN SODIUM ACTIVE INGREDIENT 4182431BJH PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 PHENYTOIN ACTIVE MOIETY 6158TKW0C5 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 LACTITOL MONOHYDRATE INACTIVE INGREDIENT UH2K6W1Y64 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-432 PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20221228_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62756-432-08 62756043208 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-08) 2008-06-30 0000-00-00 No No Current 62756-432-13 62756043213 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-13) 2008-06-30 0000-00-00 No No Current 62756-432-83 62756043283 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-83) 2008-06-30 0000-00-00 No No Current 62756-432-88 62756043288 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-432-88) 2008-06-30 0000-00-00 No No Current