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United States · US · US:68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47
erythromycin lactobionate
Orange BookUNIISPLATC D10AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeD10AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680835131010 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01)
Annotations
UNII (FDA Substance ID)
33H58I7GLQ
ERYTHROMYCIN LACTOBIONATE
RxCUI 24347
Orange Book
A216761
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "33H58I7GLQ",
"rxcui": "24347",
"inchikey": "NNRXCKZMQLFUPL-WBMZRJHASA-N",
"display_name": "ERYTHROMYCIN LACTOBIONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"a7f7faaf-dc05-4d51-86c6-bf5d61562e48": {
"match": "brand_token",
"title": "ERYTHROMYCIN ETHYLSUCCINATE FOR SUSPENSION [KANCHAN HEALTHCARE INC]",
"spl_version": "7",
"published_date": "2026-05-21"
}
},
"productid": "68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47",
"productndc": "68083-513",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "216761",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 19, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERYTHROMYCIN LACTOBIONATE",
"proprietary_name": "erythromycin lactobionate",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA216761",
"marketing_category": "ANDA",
"nonproprietary_name": "erythromycin lactobionate",
"start_marketing_date": "20241119",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code D10AF.
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