🇺🇸
United States · US · US:11673-111_b9e6809c-e0ce-4205-98c5-665af1716503
DYE-FREE CHILDRENS LORATADINE
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUP & UP
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1111673111303 BLISTER PACK in 1 CARTON (11673-111-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A210088
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": {
"48744daa-7079-283d-e063-6394a90a2c9a": {
"match": "brand_token",
"title": "DYE-FREE LORATADINE (LORATADINE) TABLET, CHEWABLE [OHM LABORATORIES INC.]",
"spl_version": "2",
"published_date": "2026-05-21"
}
},
"productid": "11673-111_b9e6809c-e0ce-4205-98c5-665af1716503",
"productndc": "11673-111",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "210088",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Apr 16, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Apr 25, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "DYE-FREE CHILDRENS LORATADINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210088",
"marketing_category": "ANDA",
"nonproprietary_name": "LORATADINE",
"start_marketing_date": "20201117",
"active_numerator_strength": "5"
}Related drugs
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