Package 68083-388-01

Brand: dexrazoxane

Generic: dexrazoxane for injection
NDC Package

Package Facts

Identity

Package NDC 68083-388-01
Digits Only 6808338801
Product NDC 68083-388
Product ID 68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677
Description

1 VIAL in 1 CARTON (68083-388-01) / 25 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2019-12-16
Brand dexrazoxane
Generic dexrazoxane for injection
Sample Package No

Linked Drug Pages (1)

Dexrazoxane ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "31a8c608-3ad6-44fe-aec8-621a8b991677", "openfda": {"upc": ["0368083388010", "0368083195014"], "unii": ["5346058Q7S"], "rxcui": ["1736585", "1736590"], "spl_set_id": ["c9c625fc-8852-4ed4-bcf2-63f46a706782"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-388-01)  / 25 mL in 1 VIAL", "package_ndc": "68083-388-01", "marketing_start_date": "20191216"}], "brand_name": "Dexrazoxane", "product_id": "68083-388_31a8c608-3ad6-44fe-aec8-621a8b991677", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytoprotective Agent [EPC]"], "product_ndc": "68083-388", "generic_name": "Dexrazoxane for Injection", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexrazoxane", "active_ingredients": [{"name": "DEXRAZOXANE HYDROCHLORIDE", "strength": "250 mg/25mL"}], "application_number": "ANDA207321", "marketing_category": "ANDA", "marketing_start_date": "20191216", "listing_expiration_date": "20261231"}