Package 0955-3900-03

Brand: insulin glargine u-300

Generic: insulin glargine
NDC Package

Package Facts

Identity

Package NDC 0955-3900-03
Digits Only 0955390003
Product NDC 0955-3900
Product ID 0955-3900_63c52b96-0bdf-42f0-9c6c-e439846e6926
Description

3 SYRINGE in 1 CARTON (0955-3900-03) / 1.5 mL in 1 SYRINGE (0955-3900-01)

Marketing

Marketing Status
Marketed Since 2023-04-01
Brand insulin glargine u-300
Generic insulin glargine
Sample Package No

Linked Drug Pages (1)

Insulin glargine U-300 Max, Insulin glargine U-300 ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "63c52b96-0bdf-42f0-9c6c-e439846e6926", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["1604539", "2002419"], "spl_set_id": ["99ea856d-9562-443a-9422-1006a3cff2f4"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 SYRINGE in 1 CARTON (0955-3900-03)  / 1.5 mL in 1 SYRINGE (0955-3900-01)", "package_ndc": "0955-3900-03", "marketing_start_date": "20230401"}], "brand_name": "Insulin glargine U-300", "product_id": "0955-3900_63c52b96-0bdf-42f0-9c6c-e439846e6926", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0955-3900", "generic_name": "insulin glargine", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Insulin glargine U-300", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "300 [iU]/mL"}], "application_number": "BLA206538", "marketing_category": "BLA", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}