🇺🇸
United States · US · US:11523-0101_4526da60-c33b-fb4a-e063-6294a90a8692
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 · 3
- ndc1111523010111 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLE
- ndc1111523010121 BOTTLE in 1 CARTON (11523-0101-2) / 80 mL in 1 BOTTLE
- ndc1111523010131 BOTTLE in 1 CARTON (11523-0101-3) / 240 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
N020641
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": "11523-0101_4526da60-c33b-fb4a-e063-6294a90a8692",
"productndc": "11523-0101",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "020641",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG/ML",
"product_no": "002",
"approval_date": "Nov 27, 2002"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "003",
"approval_date": "Nov 19, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Claritin",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020641",
"marketing_category": "NDA",
"nonproprietary_name": "loratadine",
"start_marketing_date": "20240522",
"active_numerator_strength": "1"
}Related drugs
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