Package 70518-4325-0
Brand: dilantin
Generic: extended phenytoin sodiumPackage Facts
Identity
Package NDC
70518-4325-0
Digits Only
7051843250
Product NDC
70518-4325
Description
100 POUCH in 1 BOX (70518-4325-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4325-1)
Marketing
Marketing Status
Brand
dilantin
Generic
extended phenytoin sodium
Sample Package
No
Linked Drug Pages (0)
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"}