Package 62935-163-60

Brand: fensolvi

Generic: leuprolide acetate
NDC Package

Package Facts

Identity

Package NDC 62935-163-60
Digits Only 6293516360
Product NDC 62935-163
Description

1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2023-03-06
Brand fensolvi
Generic leuprolide acetate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "6ad49800-db23-42bb-8543-1bbb6a9c96f2", "openfda": {"unii": ["37JNS02E7V"], "rxcui": ["752884", "2371773"], "spl_set_id": ["2c311700-edf4-4f2a-a468-9875489a6cc7"], "manufacturer_name": ["TOLMAR Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (62935-163-60)  / .375 mL in 1 SYRINGE", "package_ndc": "62935-163-60", "marketing_start_date": "20230306"}], "brand_name": "Fensolvi", "product_id": "62935-163_6ad49800-db23-42bb-8543-1bbb6a9c96f2", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Gonadotropin Releasing Hormone Receptor Agonist [EPC]", "Gonadotropin Releasing Hormone Receptor Agonists [MoA]"], "product_ndc": "62935-163", "generic_name": "Leuprolide Acetate", "labeler_name": "TOLMAR Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fensolvi", "active_ingredients": [{"name": "LEUPROLIDE ACETATE", "strength": "45 mg/.375mL"}], "application_number": "NDA213150", "marketing_category": "NDA", "marketing_start_date": "20230306", "listing_expiration_date": "20261231"}