🇺🇸
United States · US · US:49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0
Loratadine 10 mg
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTIME CAP LABORATORIES, INC.
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114948373265365 TABLET in 1 BOTTLE (49483-732-65)
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": "49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0",
"productndc": "49483-732",
"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 10 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219223",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine Tablets USP, 10 mg",
"start_marketing_date": "20250125",
"active_numerator_strength": "10"
}Related drugs
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