Package 0378-2670-01

Brand: phenytek

Generic: extended phenytoin sodium
NDC Package

Package Facts

Identity

Package NDC 0378-2670-01
Digits Only 0378267001
Product NDC 0378-2670
Description

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)

Marketing

Marketing Status
Marketed Since 2001-12-10
Brand phenytek
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": "a532ea94-0186-4554-969c-66ff80f95c94", "openfda": {"upc": ["0303783750934", "0303782670936"], "unii": ["4182431BJH"], "rxcui": ["855861", "855863", "855873", "855875"], "spl_set_id": ["0f94c791-8b07-4b41-927e-c9f28bec5f60"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)", "package_ndc": "0378-2670-01", "marketing_start_date": "20011210"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-93)", "package_ndc": "0378-2670-93", "marketing_start_date": "20011210"}], "brand_name": "Phenytek", "product_id": "0378-2670_a532ea94-0186-4554-969c-66ff80f95c94", "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": "0378-2670", "generic_name": "extended phenytoin sodium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytek", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "200 mg/1"}], "application_number": "ANDA040298", "marketing_category": "ANDA", "marketing_start_date": "20011210", "listing_expiration_date": "20261231"}