🇺🇸
United States · US · US:63548-0753_c24222bc-72ef-4c15-b7c2-9401fe5f40a6
Loratadine
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPLD Acquisitions LLC DBA Av�ma Pharma Solutions
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116354807530300 TABLET in 1 BOTTLE, PLASTIC (63548-0753-0)
- ndc116354807531100 TABLET in 1 BOTTLE, PLASTIC (63548-0753-1)
- ndc11635480753330 TABLET in 1 BOTTLE, PLASTIC (63548-0753-3)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A075209
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": "63548-0753_c24222bc-72ef-4c15-b7c2-9401fe5f40a6",
"productndc": "63548-0753",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075209",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jan 21, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075209",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20181030",
"active_numerator_strength": "10"
}Related drugs
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