Package 68083-503-01

Brand: thiotepa

Generic: thiotepa
NDC Package

Package Facts

Identity

Package NDC 68083-503-01
Digits Only 6808350301
Product NDC 68083-503
Description

1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Marketing

Marketing Status
Marketed Since 2022-01-03
Brand thiotepa
Generic thiotepa
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRACAVITARY", "INTRAVENOUS", "INTRAVESICAL"], "spl_id": "164faf7b-519a-41f7-a760-eb2a81b9f040", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0368083503017"], "unii": ["905Z5W3GKH"], "rxcui": ["1660004", "1660009"], "spl_set_id": ["6cd6ae89-c553-4328-9262-4363610a1f19"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-503-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "68083-503-01", "marketing_start_date": "20220103"}], "brand_name": "Thiotepa", "product_id": "68083-503_164faf7b-519a-41f7-a760-eb2a81b9f040", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "68083-503", "generic_name": "Thiotepa", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thiotepa", "active_ingredients": [{"name": "THIOTEPA", "strength": "100 mg/1"}], "application_number": "ANDA214222", "marketing_category": "ANDA", "marketing_start_date": "20220103", "listing_expiration_date": "20271231"}