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United States · US · US:0113-2007_625c73b9-b448-4e9b-a1e6-359d5cb33eb0
Allergy and Congestion Relief
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11011320076020 BLISTER PACK in 1 CARTON (0113-2007-60) / 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": {
"934c7b91-3cba-47f0-8efa-77216f3f15c4": {
"match": "brand_token",
"title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
"spl_version": "14",
"published_date": "2026-06-01"
}
},
"productid": "0113-2007_625c73b9-b448-4e9b-a1e6-359d5cb33eb0",
"productndc": "0113-2007",
"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": "Allergy and Congestion Relief",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA076050",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine, Pseudoephedrine sulfate",
"start_marketing_date": "20180412",
"active_numerator_strength": "5; 120"
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