🇺🇸
United States · US · US:70000-0611_edf22989-fa56-4d83-9b88-912e0d14ac86
leader migraine relief
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170000061111 BOTTLE in 1 CARTON (70000-0611-1) / 80 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A075794
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"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": "70000-0611_edf22989-fa56-4d83-9b88-912e0d14ac86",
"productndc": "70000-0611",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075794",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG;250MG;65MG",
"product_no": "001",
"approval_date": "Nov 26, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "leader migraine relief",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA075794",
"marketing_category": "ANDA",
"nonproprietary_name": "acetaminophen, aspirin, caffeine",
"start_marketing_date": "20220808",
"active_numerator_strength": "250; 250; 65"
}Related drugs
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