🇺🇸
United States · US · US:49035-488_32b910db-c0a5-104e-e063-6294a90a3012
Loratadine and Pseudoephedrine Sulfate
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWAL-MART STORES, INC
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11490354881515 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-15)
- ndc11490354886910 TABLET, EXTENDED RELEASE in 1 CARTON (49035-488-69)
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": "49035-488_32b910db-c0a5-104e-e063-6294a90a3012",
"productndc": "49035-488",
"dosage_form": "TABLET, 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": "20200615",
"active_numerator_strength": "10; 240"
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