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United States · US · US:85742-030_56b7e7ad-dd16-44aa-8b65-0fb27e5f49b4

Erythromycin ethylsuccinate

Orange BookUNIISPLATC D10AF

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKanchan Healthcare Inc
CountryUS (United States)
ATC codeD10AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8574203028
    100 mL in 1 BOTTLE (85742-030-28)

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": "85742-030_56b7e7ad-dd16-44aa-8b65-0fb27e5f49b4",
  "productndc": "85742-030",
  "dosage_form": "FOR 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": "20221121",
  "active_numerator_strength": "400"
}

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