Erythromycin Ethylsuccinate

Orange BookUNIISPLATC D10AF

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeD10AF

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6255963101
100 mL in 1 BOTTLE (62559-631-01)

Annotations

UNII (FDA Substance ID)

1014KSJ86F

ERYTHROMYCIN ETHYLSUCCINATE

RxCUI 4056

Orange Book

A062055

ABABAB

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": "62559-631_9bae85e8-ec96-4424-a640-27860f8f319e",
  "productndc": "62559-631",
  "dosage_form": "GRANULE, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "062055",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Nov 2, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE/5ML",
        "product_no": "003",
        "approval_date": "Nov 2, 2018"
      }
    ],
    "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": "ANDA062055",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Erythromycin Ethylsuccinate",
  "start_marketing_date": "20190325",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code D10AF.

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