Package 0517-0602-01
Brand: injectafer
Generic: ferric carboxymaltose injectionPackage Facts
Identity
Package NDC
0517-0602-01
Digits Only
0517060201
Product NDC
0517-0602
Description
1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
injectafer
Generic
ferric carboxymaltose injection
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "a092ebb6-505b-464f-9669-194a913ff8e5", "openfda": {"unii": ["6897GXD6OE"], "rxcui": ["1435169", "1435174", "2552400", "2552401", "2602296", "2602297"], "spl_set_id": ["517b4a19-45b3-4286-9f6a-ced4e10447de"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0517-0602-01", "marketing_start_date": "20220728"}], "brand_name": "Injectafer", "product_id": "0517-0602_a092ebb6-505b-464f-9669-194a913ff8e5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Iron [CS]", "Parenteral Iron Replacement [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0517-0602", "generic_name": "Ferric Carboxymaltose Injection", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Injectafer", "active_ingredients": [{"name": "FERRIC CARBOXYMALTOSE", "strength": "50 mg/mL"}], "application_number": "NDA203565", "marketing_category": "NDA", "marketing_start_date": "20220601", "listing_expiration_date": "20261231"}