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United States · US · US:68788-8480_e91d16a6-1d59-4cd6-842d-b75fa5839b4f
Clarithromycin
Orange BookUNIISPLATC J01FA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01FA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11687888480220 TABLET, FILM COATED in 1 BOTTLE (68788-8480-2)
- ndc11687888480828 TABLET, FILM COATED in 1 BOTTLE (68788-8480-8)
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": "68788-8480_e91d16a6-1d59-4cd6-842d-b75fa5839b4f",
"productndc": "68788-8480",
"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": "20230713",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01FA09.
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