🇺🇸
United States · US · US:49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332
Childrens Allergy
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWal-Mart Stores Inc
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1149035538081 BOTTLE in 1 CARTON (49035-538-08) / 120 mL in 1 BOTTLE
- ndc1149035538091 BOTTLE in 1 CARTON (49035-538-09) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A201865
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": "49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332",
"productndc": "49035-538",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "201865",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Jul 31, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Childrens Allergy",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA201865",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20161208",
"active_numerator_strength": "5"
}Related drugs
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