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United States · US · US:0591-2805_d97b84fc-7e0b-4f73-804d-522c2448b058
clarithromycin
Orange BookUNIISPLATC J01FA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeJ01FA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11059128056060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60)
Annotations
UNII (FDA Substance ID)
H1250JIK0A
CLARITHROMYCIN
RxCUI 21212
Orange Book
A065145
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": "0591-2805_d97b84fc-7e0b-4f73-804d-522c2448b058",
"productndc": "0591-2805",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "065145",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jun 24, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLARITHROMYCIN",
"proprietary_name": "clarithromycin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065145",
"marketing_category": "ANDA",
"nonproprietary_name": "clarithromycin",
"start_marketing_date": "20140227",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01FA09.
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