Package 0641-6139-10

Brand: phenytoin sodium

Generic: phenytoin sodium
NDC Package

Package Facts

Identity

Package NDC 0641-6139-10
Digits Only 0641613910
Product NDC 0641-6139
Description

10 VIAL in 1 CARTON (0641-6139-10) / 5 mL in 1 VIAL (0641-6139-01)

Marketing

Marketing Status
Marketed Since 2023-09-22
Brand phenytoin sodium
Generic phenytoin sodium
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "8c2cd4dc-57c1-48b8-8005-95c5a5593e7c", "openfda": {"unii": ["4182431BJH"], "rxcui": ["1670351", "1670353"], "spl_set_id": ["8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6139-10)  / 5 mL in 1 VIAL (0641-6139-01)", "package_ndc": "0641-6139-10", "marketing_start_date": "20230922"}, {"sample": false, "description": "25 VIAL in 1 CARTON (0641-6139-25)  / 5 mL in 1 VIAL (0641-6139-01)", "package_ndc": "0641-6139-25", "marketing_start_date": "19750716"}], "brand_name": "Phenytoin Sodium", "product_id": "0641-6139_8c2cd4dc-57c1-48b8-8005-95c5a5593e7c", "dosage_form": "INJECTION", "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": "0641-6139", "generic_name": "Phenytoin Sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA084307", "marketing_category": "ANDA", "marketing_start_date": "19750716", "listing_expiration_date": "20261231"}