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United States · US · US:50090-0994_b17c8e0b-5db9-4116-9073-8e8fac3459dc
Clarithromycin
Orange BookUNIISPLATC J01FA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01FA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500900994050 mL in 1 BOTTLE (50090-0994-0)
Annotations
UNII (FDA Substance ID)
H1250JIK0A
CLARITHROMYCIN
RxCUI 21212
Orange Book
A065283
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": "50090-0994_b17c8e0b-5db9-4116-9073-8e8fac3459dc",
"productndc": "50090-0994",
"dosage_form": "FOR SUSPENSION",
"orange_book": {
"appl_no": "065283",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "125MG/5ML",
"product_no": "002",
"approval_date": "Sep 4, 2007"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "250MG/5ML",
"product_no": "003",
"approval_date": "Sep 4, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLARITHROMYCIN",
"proprietary_name": "Clarithromycin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065283",
"marketing_category": "ANDA",
"nonproprietary_name": "Clarithromycin",
"start_marketing_date": "20070904",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01FA09.
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