erythromycin lactobionate

Generic: erythromycin lactobionate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin lactobionate
Generic Name erythromycin lactobionate
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

erythromycin lactobionate 500 mg/10mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-513
Product ID 68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216761
Listing Expiration 2026-12-31
Marketing Start 2024-11-19

Pharmacologic Class

Classes
decreased sebaceous gland activity [pe] macrolide antimicrobial [epc] macrolide [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083513
Hyphenated Format 68083-513

Supplemental Identifiers

RxCUI
1668264
UPC
0368083513016
UNII
33H58I7GLQ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name erythromycin lactobionate (source: ndc)
Generic Name erythromycin lactobionate (source: ndc)
Application Number ANDA216761 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01)
source: ndc

Packages (1)

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

Ingredients (1)

erythromycin lactobionate (500 mg/10mL)

Linked Drug Pages (1)

erythromycin lactobionate ndc-match (0.9)

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"}