🇺🇸
United States · US · US:63654-309_39201d37-e750-420b-8035-feb97bc77c21
Allergy
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSelder, S.A. de C.V.
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163654309101 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076471
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": "63654-309_39201d37-e750-420b-8035-feb97bc77c21",
"productndc": "63654-309",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076471",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Feb 14, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Allergy",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076471",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20141216",
"active_numerator_strength": "10"
}Related drugs
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