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United States · US · US:72189-299_2c2941fa-11d7-9f72-e063-6394a90af886

Clarithromycin

Orange BookUNIISPLATC J01FA09

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

Identification

ManufacturerDirectRx
CountryUS (United States)
ATC codeJ01FA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7218929910
    10 TABLET in 1 BOTTLE (72189-299-10)
  • ndc11
    7218929920
    20 TABLET in 1 BOTTLE (72189-299-20)
  • ndc11
    7218929928
    28 TABLET in 1 BOTTLE (72189-299-28)

Annotations

UNII (FDA Substance ID)
H1250JIK0A
CLARITHROMYCIN
RxCUI 21212
Orange Book
A065136
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "H1250JIK0A",
    "rxcui": "21212",
    "inchikey": "AGOYDEPGAOXOCK-KCBOHYOISA-N",
    "display_name": "CLARITHROMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "de33ba3a-9df1-4076-8d5f-b603d2698096": {
      "match": "brand_token",
      "title": "CLARITHROMYCIN TABLET, FILM COATED [SPORTPHARM LLC]",
      "spl_version": "1",
      "published_date": "2026-04-23"
    }
  },
  "productid": "72189-299_2c2941fa-11d7-9f72-e063-6394a90af886",
  "productndc": "72189-299",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "065136",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Aug 25, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLARITHROMYCIN",
  "proprietary_name": "Clarithromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065136",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clarithromycin",
  "start_marketing_date": "20211202",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01FA09.

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