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United States · US · US:0113-9004_512f8f46-5c62-470d-b14a-93b86ec34ce8
allergy d
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
- ndc11011390042215 BLISTER PACK in 1 CARTON (0113-9004-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A075989
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": "0113-9004_512f8f46-5c62-470d-b14a-93b86ec34ce8",
"productndc": "0113-9004",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075989",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG;240MG",
"product_no": "001",
"approval_date": "Mar 4, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"proprietary_name": "allergy d",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA075989",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine, pseudoephedrine sulfate",
"start_marketing_date": "20251003",
"active_numerator_strength": "10; 240"
}Related drugs
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