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United States · US · US:45802-038_81c83ddb-5432-484c-8a60-e51677a62c6b

erythromycin

Orange BookUNIISPLATC S01AA17

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeS01AA17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4580203846
    1 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
63937KV33D
ERYTHROMYCIN
RxCUI 4053
Orange Book
A063038
AT
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": "TOPICAL",
  "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": "45802-038_81c83ddb-5432-484c-8a60-e51677a62c6b",
  "productndc": "45802-038",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "063038",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Jan 11, 1991"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERYTHROMYCIN",
  "proprietary_name": "erythromycin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA063038",
  "marketing_category": "ANDA",
  "nonproprietary_name": "erythromycin",
  "start_marketing_date": "20111219",
  "active_numerator_strength": "20"
}

Related drugs

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