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United States · US · US:68788-4103_7ca5050a-328a-4aff-8954-58f092e3ed6b
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
- ndc11687884103010 TABLET in 1 BOTTLE (68788-4103-0)
- ndc11687884103114 TABLET in 1 BOTTLE (68788-4103-1)
- ndc11687884103330 TABLET in 1 BOTTLE (68788-4103-3)
- ndc11687884103515 TABLET in 1 BOTTLE (68788-4103-5)
- ndc11687884103990 TABLET in 1 BOTTLE (68788-4103-9)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A208314
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": "68788-4103_7ca5050a-328a-4aff-8954-58f092e3ed6b",
"productndc": "68788-4103",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208314",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208314",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20260421",
"active_numerator_strength": "10"
}Related drugs
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