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United States · US · US:37808-427_58f339ff-cf7c-4d4d-9437-07ec3e2818d5
Loratadine and Pseudoephedrine Sulfate
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHEB
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11378084276910 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (37808-427-69)
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076557
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": "37808-427_58f339ff-cf7c-4d4d-9437-07ec3e2818d5",
"productndc": "37808-427",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "076557",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG;240MG",
"product_no": "001",
"approval_date": "Sep 22, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"proprietary_name": "Loratadine and Pseudoephedrine Sulfate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA076557",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine and pseudoephedrine sulfate",
"start_marketing_date": "20180201",
"active_numerator_strength": "10; 240"
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