dilantin

Generic: extended phenytoin sodium

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dilantin
Generic Name extended phenytoin sodium
Labeler viatris specialty llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-110
Product ID 58151-110_872f23a8-e6a3-4038-922d-0c26fc81d8b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084349
Listing Expiration 2026-12-31
Marketing Start 2024-12-06

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 58151110
Hyphenated Format 58151-110

Supplemental Identifiers

RxCUI
855671 855673 855869 855871
UPC
0358151118014 0358151110018
UNII
4182431BJH

Packaging Origin

Original Packager
true

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
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10)
  • 100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)
source: ndc

Packages (3)

58151-110-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01) 58151-110-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10) 58151-110-88 100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)

Ingredients (1)

phenytoin sodium (100 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": "872f23a8-e6a3-4038-922d-0c26fc81d8b3", "openfda": {"upc": ["0358151118014", "0358151110018"], "unii": ["4182431BJH"], "rxcui": ["855671", "855673", "855869", "855871"], "spl_set_id": ["86dd27d1-9cee-48ae-b55d-e2d2f7dbc593"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01)", "package_ndc": "58151-110-01", "marketing_start_date": "20241206"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10)", "package_ndc": "58151-110-10", "marketing_start_date": "20250409"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (58151-110-88)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)", "package_ndc": "58151-110-88", "marketing_start_date": "20241206"}], "brand_name": "DILANTIN", "product_id": "58151-110_872f23a8-e6a3-4038-922d-0c26fc81d8b3", "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": "58151-110", "generic_name": "Extended Phenytoin Sodium", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DILANTIN", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA084349", "marketing_category": "ANDA", "marketing_start_date": "20241206", "listing_expiration_date": "20261231"}