🇺🇸
United States · US · US:68788-8616_8d420971-3031-42af-9fbb-22a99001f291
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 · 6
- ndc116878886160100 TABLET in 1 BOTTLE (68788-8616-0)
- ndc11687888616114 TABLET in 1 BOTTLE (68788-8616-1)
- ndc11687888616330 TABLET in 1 BOTTLE (68788-8616-3)
- ndc11687888616515 TABLET in 1 BOTTLE (68788-8616-5)
- ndc11687888616810 TABLET in 1 BOTTLE (68788-8616-8)
- ndc11687888616990 TABLET in 1 BOTTLE (68788-8616-9)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A214684
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": "68788-8616_8d420971-3031-42af-9fbb-22a99001f291",
"productndc": "68788-8616",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214684",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jan 7, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214684",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine",
"start_marketing_date": "20240326",
"active_numerator_strength": "10"
}Related drugs
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