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United States · US · US:41520-131_28dbc446-66f2-7eb5-e063-6294a90a1d1a
Childrens Loratadine
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1141520131081 BOTTLE in 1 CARTON (41520-131-08) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076805
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": {
"436c0126-4ff3-c082-e063-6294a90a3d72": {
"match": "brand_token",
"title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "41520-131_28dbc446-66f2-7eb5-e063-6294a90a1d1a",
"productndc": "41520-131",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "076805",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Aug 20, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Childrens Loratadine",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA076805",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20170317",
"active_numerator_strength": "5"
}Related drugs
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