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United States · US · US:50090-6078_049a1f87-10ee-4c8a-858b-218611764bff

MUCINEX

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009060780
    480 TABLET, EXTENDED RELEASE in 1 CASE (50090-6078-0)

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
N021282
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "495W7451VQ",
    "rxcui": "5032",
    "inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
    "display_name": "GUAIFENESIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "49f1f415-8017-0974-e063-6294a90a8918": {
      "match": "brand_token",
      "title": "MUCINEX 12HR COLD AND FEVER MULTI-SYMPTOM (NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "50090-6078_049a1f87-10ee-4c8a-858b-218611764bff",
  "productndc": "50090-6078",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021282",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Jul 12, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "Dec 18, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "MUCINEX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021282",
  "marketing_category": "NDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20120703",
  "active_numerator_strength": "600"
}

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