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United States · US · US:70000-0669_1c6314df-4429-4d58-bdc2-12830d55f036
Leader Miconazole 3
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170000066911 KIT in 1 CARTON (70000-0669-1) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE
Annotations
Orange Book
A076357
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "70000-0669_1c6314df-4429-4d58-bdc2-12830d55f036",
"productndc": "70000-0669",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "076357",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2%,4%",
"product_no": "001",
"approval_date": "Mar 30, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": null,
"proprietary_name": "Leader Miconazole 3",
"active_ingred_unit": null,
"application_number": "ANDA076357",
"marketing_category": "ANDA",
"nonproprietary_name": "Miconazole nitrate",
"start_marketing_date": "20240627",
"active_numerator_strength": null
}Access this data programmatically
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