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United States · US · US:85766-047_4a2c3181-73fa-906a-e063-6294a90a6479
loratadine D
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11857660471010 BLISTER PACK in 1 CARTON (85766-047-10) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076050
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": "85766-047_4a2c3181-73fa-906a-e063-6294a90a6479",
"productndc": "85766-047",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "076050",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG;120MG",
"product_no": "001",
"approval_date": "Jan 30, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"proprietary_name": "loratadine D",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA076050",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine, Pseudoephedrine sulfate",
"start_marketing_date": "20180410",
"active_numerator_strength": "5; 120"
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