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United States · US · US:71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5

Clarithromycin

Orange BookUNIISPLATC J01FA09

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

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
    7133514931
    20 TABLET in 1 BOTTLE (71335-1493-1)
  • ndc11
    7133514932
    14 TABLET in 1 BOTTLE (71335-1493-2)
  • ndc11
    7133514933
    30 TABLET in 1 BOTTLE (71335-1493-3)
  • ndc11
    7133514934
    21 TABLET in 1 BOTTLE (71335-1493-4)
  • ndc11
    7133514935
    28 TABLET in 1 BOTTLE (71335-1493-5)
  • ndc11
    7133514936
    60 TABLET in 1 BOTTLE (71335-1493-6)
  • ndc11
    7133514937
    90 TABLET in 1 BOTTLE (71335-1493-7)
  • ndc11
    7133514938
    10 TABLET in 1 BOTTLE (71335-1493-8)
  • ndc11
    7133514939
    180 TABLET in 1 BOTTLE (71335-1493-9)

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": "71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5",
  "productndc": "71335-1493",
  "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": "20050825",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01FA09.

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