Clarithromycin

Orange BookUNIISPLATC J01FA09

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ01FA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6318737614
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-14)
ndc11
6318737620
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-20)
ndc11
6318737628
28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-28)
ndc11
6318737630
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-30)
ndc11
6318737660
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-60)
ndc11
6318737690
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-90)

Annotations

UNII (FDA Substance ID)

H1250JIK0A

CLARITHROMYCIN

RxCUI 21212

Orange Book

A203584

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": "63187-376_f6ee6e86-2078-4354-9def-3f94fc7b6a6c",
  "productndc": "63187-376",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203584",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLARITHROMYCIN",
  "proprietary_name": "Clarithromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203584",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clarithromycin",
  "start_marketing_date": "20151204",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01FA09.

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