Package 81927-106-01

Brand: tepylute

Generic: thiotepa
NDC Package

Package Facts

Identity

Package NDC 81927-106-01
Digits Only 8192710601
Product NDC 81927-106
Product ID 81927-106_ea45bb79-9b31-48f4-9785-a94c3be6c1e9
Description

1 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01) / 10 mL in 1 VIAL, MULTI-DOSE

Marketing

Marketing Status
Marketed Since 2025-03-31
Brand tepylute
Generic thiotepa
Sample Package No

Linked Drug Pages (1)

TEPYLUTE ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea45bb79-9b31-48f4-9785-a94c3be6c1e9", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["905Z5W3GKH"], "rxcui": ["2700709", "2700712", "2709440", "2709442"], "spl_set_id": ["add44e98-a042-4e38-b870-beb36693805b"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Shorla Oncology Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "81927-106-01", "marketing_start_date": "20250331"}], "brand_name": "TEPYLUTE", "product_id": "81927-106_ea45bb79-9b31-48f4-9785-a94c3be6c1e9", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "81927-106", "generic_name": "thiotepa", "labeler_name": "Shorla Oncology Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEPYLUTE", "active_ingredients": [{"name": "THIOTEPA", "strength": "10 mg/mL"}], "application_number": "NDA216984", "marketing_category": "NDA", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}