Clarithromycin

Orange BookUNIISPLATC J01FA09

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeJ01FA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7133500171
20 TABLET, FILM COATED in 1 BOTTLE (71335-0017-1)
ndc11
7133500172
14 TABLET, FILM COATED in 1 BOTTLE (71335-0017-2)
ndc11
7133500173
30 TABLET, FILM COATED in 1 BOTTLE (71335-0017-3)
ndc11
7133500174
21 TABLET, FILM COATED in 1 BOTTLE (71335-0017-4)
ndc11
7133500175
28 TABLET, FILM COATED in 1 BOTTLE (71335-0017-5)
ndc11
7133500176
60 TABLET, FILM COATED in 1 BOTTLE (71335-0017-6)
ndc11
7133500177
90 TABLET, FILM COATED in 1 BOTTLE (71335-0017-7)
ndc11
7133500178
10 TABLET, FILM COATED in 1 BOTTLE (71335-0017-8)
ndc11
7133500179
180 TABLET, FILM COATED in 1 BOTTLE (71335-0017-9)

Annotations

UNII (FDA Substance ID)

H1250JIK0A

CLARITHROMYCIN

RxCUI 21212

Orange Book

A065489

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": "71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d",
  "productndc": "71335-0017",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065489",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 25, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jul 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLARITHROMYCIN",
  "proprietary_name": "Clarithromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065489",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clarithromycin",
  "start_marketing_date": "20120725",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01FA09.

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