🇺🇸
United States · US · US:25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629
Loratadine 10mg
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1125000092031 BOTTLE in 1 CARTON (25000-092-03) / 30 TABLET in 1 BOTTLE
- ndc1125000092791 BOTTLE in 1 CARTON (25000-092-79) / 150 TABLET in 1 BOTTLE
- ndc112500009280365 TABLET in 1 BOTTLE (25000-092-80)
- ndc1125000092812 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A219223
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": "25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629",
"productndc": "25000-092",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219223",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 21, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Loratadine 10mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219223",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine 10mg",
"start_marketing_date": "20241121",
"active_numerator_strength": "10"
}Related drugs
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