Package 58151-118-01

Brand: dilantin

Generic: extended phenytoin sodium
NDC Package

Package Facts

Identity

Package NDC 58151-118-01
Digits Only 5815111801
Product NDC 58151-118
Description

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-118-01)

Marketing

Marketing Status
Marketed Since 2025-01-15
Brand dilantin
Generic extended phenytoin sodium
Sample Package No

Linked Drug Pages (1)

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 (58151-118-01)", "package_ndc": "58151-118-01", "marketing_start_date": "20250115"}], "brand_name": "DILANTIN", "product_id": "58151-118_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": "58151-118", "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": "30 mg/1"}], "application_number": "ANDA084349", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}