Package 0078-0674-61
Brand: hycamtin
Generic: topotecan hydrochloridePackage Facts
Identity
Package NDC
0078-0674-61
Digits Only
0078067461
Product NDC
0078-0674
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
hycamtin
Generic
topotecan hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "e6e4f66b-e398-44d3-a832-e5a809f3e861", "openfda": {"unii": ["956S425ZCY"], "rxcui": ["637550", "1799416"], "spl_set_id": ["eeee060c-a9ec-423e-a374-8484009f8524"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0078-0674-61", "marketing_start_date": "20161221"}], "brand_name": "HYCAMTIN", "product_id": "0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0078-0674", "generic_name": "topotecan hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYCAMTIN", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": "4 mg/4mL"}], "application_number": "NDA020671", "marketing_category": "NDA", "marketing_start_date": "20161221", "listing_expiration_date": "20261231"}