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United States · US · US:11523-0800_4526e2eb-ee8d-3ac4-e063-6394a90a133f
Claritin
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare LLC.
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1111523080011 BLISTER PACK in 1 CARTON (11523-0800-1) / 5 TABLET in 1 BLISTER PACK
- ndc111152308002100 TABLET in 1 BOTTLE (11523-0800-2)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A075209
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7AJO3BO7QN",
"rxcui": "28889",
"inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
"display_name": "LORATADINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8e14b61f-faf6-43a8-a080-75f64514217a": {
"match": "brand_token",
"title": "CLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]",
"spl_version": "13",
"published_date": "2026-02-09"
}
},
"productid": "11523-0800_4526e2eb-ee8d-3ac4-e063-6394a90a133f",
"productndc": "11523-0800",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075209",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jan 21, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Claritin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075209",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine",
"start_marketing_date": "20201201",
"active_numerator_strength": "10"
}Related drugs
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