🇺🇸
United States · US · US:68788-8605_48cbeb9b-de13-4330-97b2-f87fb7e26cb9
Loratadine
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11687888605010 TABLET in 1 BOTTLE (68788-8605-0)
- ndc11687888605114 TABLET in 1 BOTTLE (68788-8605-1)
- ndc11687888605330 TABLET in 1 BOTTLE (68788-8605-3)
- ndc11687888605515 TABLET in 1 BOTTLE (68788-8605-5)
- ndc11687888605990 TABLET in 1 BOTTLE (68788-8605-9)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A211718
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": {
"d778c4d2-184a-4dc8-9351-66d81d0618f2": {
"match": "brand_token",
"title": "LORATADINE TABLET [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "68788-8605_48cbeb9b-de13-4330-97b2-f87fb7e26cb9",
"productndc": "68788-8605",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211718",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 28, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211718",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20240313",
"active_numerator_strength": "10"
}Related drugs
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