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United States · US · US:0904-6852_7c3836c3-7476-49b8-ac03-11718d17c813
Loratadine
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1109046852721 BOTTLE in 1 CARTON (0904-6852-72) / 300 TABLET in 1 BOTTLE
- ndc1109046852891 BOTTLE in 1 CARTON (0904-6852-89) / 90 TABLET in 1 BOTTLE
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": "0904-6852_7c3836c3-7476-49b8-ac03-11718d17c813",
"productndc": "0904-6852",
"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": "20050221",
"active_numerator_strength": "10"
}Related drugs
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