🇺🇸
United States · US · US:0781-6022_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc
Clarithromycin
Orange BookUNIISPLATC J01FA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01FA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110781602246100 mL in 1 BOTTLE (0781-6022-46)
- ndc11078160225250 mL in 1 BOTTLE (0781-6022-52)
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": "0781-6022_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc",
"productndc": "0781-6022",
"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": "125"
}Related drugs
Other records sharing ATC code J01FA09.
Access this data programmatically
Query Clarithromycin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.