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United States · US · US:68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0
Clarithromycin
Orange BookUNIISPLATC J01FA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01FA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11680713116220 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2)
- ndc11680713116330 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3)
- ndc11680713116414 TABLET, FILM COATED in 1 BOTTLE (68071-3116-4)
- ndc11680713116828 TABLET, FILM COATED in 1 BOTTLE (68071-3116-8)
Annotations
UNII (FDA Substance ID)
H1250JIK0A
CLARITHROMYCIN
RxCUI 21212
Orange Book
A203584
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": "68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0",
"productndc": "68071-3116",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203584",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Sep 28, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Sep 28, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLARITHROMYCIN",
"proprietary_name": "Clarithromycin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203584",
"marketing_category": "ANDA",
"nonproprietary_name": "Clarithromycin",
"start_marketing_date": "20151204",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01FA09.
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