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United States · US · US:69238-1503_85c41da0-5783-4194-8bb5-7b14ad975d25

Erythromycin Ethylsuccinate

Orange BookUNIISPLATC D10AF

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeD10AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6923815031
    100 mL in 1 BOTTLE (69238-1503-1)

Annotations

UNII (FDA Substance ID)
1014KSJ86F
ERYTHROMYCIN ETHYLSUCCINATE
RxCUI 4056
Orange Book
A211204
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": "69238-1503_85c41da0-5783-4194-8bb5-7b14ad975d25",
  "productndc": "69238-1503",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "211204",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Nov 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Nov 1, 2019"
      }
    ],
    "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": "ANDA211204",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Erythromycin",
  "start_marketing_date": "20191104",
  "active_numerator_strength": "200"
}

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