🇺🇸
United States · US · US:70000-0213_ef5ff212-8517-4598-9876-2ba32b9d360b
Leader Allergy Relief
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11700000213110 BLISTER PACK in 1 CARTON (70000-0213-1) / 1 TABLET in 1 BLISTER PACK
- ndc1170000021331 BOTTLE in 1 CARTON (70000-0213-3) / 70 TABLET in 1 BOTTLE
- ndc1170000021341 BOTTLE in 1 CARTON (70000-0213-4) / 90 TABLET in 1 BOTTLE
- ndc1170000021361 BOTTLE in 1 CARTON (70000-0213-6) / 300 TABLET in 1 BOTTLE
- ndc1170000021371 BOTTLE in 1 CARTON (70000-0213-7) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076301
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": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0213_ef5ff212-8517-4598-9876-2ba32b9d360b",
"productndc": "70000-0213",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076301",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jun 25, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "Leader Allergy Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076301",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20161209",
"active_numerator_strength": "10"
}Related drugs
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