Package 68083-513-10

Brand: erythromycin lactobionate

Generic: erythromycin lactobionate
NDC Package

Package Facts

Identity

Package NDC 68083-513-10
Digits Only 6808351310
Product NDC 68083-513
Description

10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01)

Marketing

Marketing Status
Marketed Since 2024-11-19
Brand erythromycin lactobionate
Generic erythromycin lactobionate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "62d03a60-5432-4fa9-a4bb-e14276b78b47", "openfda": {"upc": ["0368083513016"], "unii": ["33H58I7GLQ"], "rxcui": ["1668264"], "spl_set_id": ["c6f9565b-6d9d-40e3-87f8-9f38ede9173a"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01)", "package_ndc": "68083-513-10", "marketing_start_date": "20241119"}], "brand_name": "erythromycin lactobionate", "product_id": "68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "68083-513", "generic_name": "erythromycin lactobionate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "erythromycin lactobionate", "active_ingredients": [{"name": "ERYTHROMYCIN LACTOBIONATE", "strength": "500 mg/10mL"}], "application_number": "ANDA216761", "marketing_category": "ANDA", "marketing_start_date": "20241119", "listing_expiration_date": "20261231"}