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United States · US · US:13668-586_8c400049-2b9b-476d-a993-06aa5d3beba9

ERYTHROMYCIN

Orange BookUNIISPLATC S01AA17

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

Identification

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

Packs · 3

  • ndc11
    1366858601
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-01)
  • ndc11
    1366858605
    500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-05)
  • ndc11
    1366858630
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-30)

Annotations

UNII (FDA Substance ID)
63937KV33D
ERYTHROMYCIN
RxCUI 4053
Orange Book
A211975
ABABAB
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": "13668-586_8c400049-2b9b-476d-a993-06aa5d3beba9",
  "productndc": "13668-586",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "211975",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 26, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jul 26, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "333MG",
        "product_no": "003",
        "approval_date": "Aug 13, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERYTHROMYCIN",
  "proprietary_name": "ERYTHROMYCIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211975",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ERYTHROMYCIN",
  "start_marketing_date": "20210726",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code S01AA17.

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