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United States · US · US:63187-100_91a17d89-5112-4176-bfa0-9fd2d27922c5
Loratadine Allergy Relief
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 · 4
- ndc11631871001010 TABLET in 1 BOTTLE (63187-100-10)
- ndc11631871002020 TABLET in 1 BOTTLE (63187-100-20)
- ndc11631871003030 TABLET in 1 BOTTLE (63187-100-30)
- ndc11631871009090 TABLET in 1 BOTTLE (63187-100-90)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076134
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": "63187-100_91a17d89-5112-4176-bfa0-9fd2d27922c5",
"productndc": "63187-100",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076134",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 18, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine Allergy Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076134",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20030828",
"active_numerator_strength": "10"
}Related drugs
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