dilantin

Generic: extended phenytoin sodium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dilantin
Generic Name extended phenytoin sodium
Labeler remedyrepack inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phenytoin sodium 30 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4325
Product ID 70518-4325_402f06b8-06fa-e2d6-e063-6294a90ad8c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084349
Listing Expiration 2026-12-31
Marketing Start 2025-04-02

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184325
Hyphenated Format 70518-4325

Supplemental Identifiers

RxCUI
855869 855871
UNII
4182431BJH

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dilantin (source: ndc)
Generic Name extended phenytoin sodium (source: ndc)
Application Number ANDA084349 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4325-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4325-1)
source: ndc

Packages (1)

70518-4325-0 100 POUCH in 1 BOX (70518-4325-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4325-1)

Ingredients (1)

phenytoin sodium (30 mg/1)

Linked Drug Pages (1)

DILANTIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "402f06b8-06fa-e2d6-e063-6294a90ad8c9", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855869", "855871"], "spl_set_id": ["db8c69b0-4697-433e-98c7-b0b2d2c52a83"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4325-0)  / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4325-1)", "package_ndc": "70518-4325-0", "marketing_start_date": "20250402"}], "brand_name": "DILANTIN", "product_id": "70518-4325_402f06b8-06fa-e2d6-e063-6294a90ad8c9", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "70518-4325", "generic_name": "Extended Phenytoin Sodium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DILANTIN", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "30 mg/1"}], "application_number": "ANDA084349", "marketing_category": "ANDA", "marketing_start_date": "20250402", "listing_expiration_date": "20261231"}