Package 68083-528-01
Brand: decitabine
Generic: decitabinePackage Facts
Identity
Package NDC
68083-528-01
Digits Only
6808352801
Product NDC
68083-528
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 10 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
decitabine
Generic
decitabine
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "39a26b24-e9d4-4974-9788-d025c51fc94f", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0368083528010"], "unii": ["776B62CQ27"], "rxcui": ["636631"], "spl_set_id": ["39a26b24-e9d4-4974-9788-d025c51fc94f"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-528-01", "marketing_start_date": "20201123"}], "brand_name": "decitabine", "product_id": "68083-528_39a26b24-e9d4-4974-9788-d025c51fc94f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-528", "generic_name": "decitabine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "decitabine", "active_ingredients": [{"name": "DECITABINE", "strength": "50 mg/10mL"}], "application_number": "ANDA205539", "marketing_category": "ANDA", "marketing_start_date": "20201123", "listing_expiration_date": "20261231"}