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United States · US · US:70000-0302_c2af792f-30a1-4f16-8b10-1822d23df4ee

Leader Cough

Orange BookUNIISPLATC N07XX59

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeN07XX59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7000003021
    1 BOTTLE in 1 CARTON (70000-0302-1) / 89 mL in 1 BOTTLE
  • ndc11
    7000003022
    1 BOTTLE in 1 CARTON (70000-0302-2) / 148 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091135
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "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": "70000-0302_c2af792f-30a1-4f16-8b10-1822d23df4ee",
  "productndc": "70000-0302",
  "dosage_form": "SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 30MG HYDROBROMIDE/5ML",
        "product_no": "001",
        "approval_date": "May 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
  "proprietary_name": "Leader Cough",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA091135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextromethorphan polistirex",
  "start_marketing_date": "20170606",
  "active_numerator_strength": "30"
}

Related drugs

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