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United States · US · US:63187-601_d36424c7-b438-4c23-884d-d4bfdac81fcf
Loratadine
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11631876011010 TABLET in 1 BOTTLE (63187-601-10)
- ndc11631876011414 TABLET in 1 BOTTLE (63187-601-14)
- ndc11631876013030 TABLET in 1 BOTTLE (63187-601-30)
- ndc11631876016060 TABLET in 1 BOTTLE (63187-601-60)
- ndc11631876019090 TABLET in 1 BOTTLE (63187-601-90)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076301
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": "63187-601_d36424c7-b438-4c23-884d-d4bfdac81fcf",
"productndc": "63187-601",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076301",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jun 25, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076301",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20081015",
"active_numerator_strength": "10"
}Related drugs
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