Clarithromycin

Orange BookUNIISPLATC J01FA09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeJ01FA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
8576619801
100 TABLET, FILM COATED in 1 BOTTLE (85766-198-01)
ndc11
8576619805
5 TABLET, FILM COATED in 1 BOTTLE (85766-198-05)
ndc11
8576619807
7 TABLET, FILM COATED in 1 BOTTLE (85766-198-07)
ndc11
8576619810
10 TABLET, FILM COATED in 1 BOTTLE (85766-198-10)
ndc11
8576619815
15 TABLET, FILM COATED in 1 BOTTLE (85766-198-15)
ndc11
8576619820
20 TABLET, FILM COATED in 1 BOTTLE (85766-198-20)
ndc11
8576619830
30 TABLET, FILM COATED in 1 BOTTLE (85766-198-30)
ndc11
8576619860
60 TABLET, FILM COATED in 1 BOTTLE (85766-198-60)
ndc11
8576619890
90 TABLET, FILM COATED in 1 BOTTLE (85766-198-90)

Annotations

UNII (FDA Substance ID)

H1250JIK0A

CLARITHROMYCIN

RxCUI 21212

Orange Book

A210459

ABAB

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": "85766-198_4fa17015-6060-4973-e063-6394a90a798d",
  "productndc": "85766-198",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210459",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jan 31, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLARITHROMYCIN",
  "proprietary_name": "Clarithromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210459",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clarithromycin",
  "start_marketing_date": "20220201",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01FA09.

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