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United States · US · US:62332-398_b4e8041f-a6b6-4f91-afad-74183c368d3c

Erythromycin

Orange BookUNIISPLATC S01AA17

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01AA17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6233239830
    30 TABLET, FILM COATED in 1 BOTTLE (62332-398-30)
  • ndc11
    6233239831
    100 TABLET, FILM COATED in 1 BOTTLE (62332-398-31)
  • ndc11
    6233239891
    1000 TABLET, FILM COATED in 1 BOTTLE (62332-398-91)

Annotations

UNII (FDA Substance ID)
63937KV33D
ERYTHROMYCIN
RxCUI 4053
Orange Book
A215661
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "63937KV33D",
    "rxcui": "4053",
    "inchikey": "ULGZDMOVFRHVEP-RWJQBGPGSA-N",
    "display_name": "ERYTHROMYCIN",
    "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": "62332-398_b4e8041f-a6b6-4f91-afad-74183c368d3c",
  "productndc": "62332-398",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215661",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Aug 24, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Aug 24, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERYTHROMYCIN",
  "proprietary_name": "Erythromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215661",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Erythromycin",
  "start_marketing_date": "20230828",
  "active_numerator_strength": "500"
}

Related drugs

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