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United States · US · US:75834-294_7f06e8f4-15fb-4e18-b57e-457e7e20d331
Erythromycin Ethylsuccinate
Orange BookUNIISPLATC D10AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNivagen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD10AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117583429401100 mL in 1 BOTTLE (75834-294-01)
Annotations
UNII (FDA Substance ID)
1014KSJ86F
ERYTHROMYCIN ETHYLSUCCINATE
RxCUI 4056
Orange Book
A216212
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1014KSJ86F",
"rxcui": "4056",
"inchikey": "NSYZCCDSJNWWJL-YXOIYICCSA-N",
"display_name": "ERYTHROMYCIN ETHYLSUCCINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"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": "75834-294_7f06e8f4-15fb-4e18-b57e-457e7e20d331",
"productndc": "75834-294",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "216212",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE/5ML",
"product_no": "001",
"approval_date": "Nov 21, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 400MG BASE/5ML",
"product_no": "002",
"approval_date": "Nov 21, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERYTHROMYCIN ETHYLSUCCINATE",
"proprietary_name": "Erythromycin Ethylsuccinate",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA216212",
"marketing_category": "ANDA",
"nonproprietary_name": "Erythromycin Ethylsuccinate",
"start_marketing_date": "20230201",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code D10AF.
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