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United States · US · US:55289-075_4199686c-7009-b215-e063-6294a90aaa02

Erythromycin

Orange BookUNIISPLATC S01AA17

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

Identification

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

Packs · 3

  • ndc11
    5528907503
    3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-075-03)
  • ndc11
    5528907540
    40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-075-40)
  • ndc11
    5528907556
    56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-075-56)

Annotations

UNII (FDA Substance ID)
63937KV33D
ERYTHROMYCIN
RxCUI 4053
Orange Book
A061621
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": "55289-075_4199686c-7009-b215-e063-6294a90aaa02",
  "productndc": "55289-075",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "061621",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERYTHROMYCIN",
  "proprietary_name": "Erythromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA061621",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Erythromycin",
  "start_marketing_date": "20110906",
  "active_numerator_strength": "250"
}

Related drugs

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