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United States · US · US:81179-007_0e127c48-e134-a961-e063-6394a90a3174

EXPECTORANT GUAIFENESIN EXTENDED-RELEASE

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerYET HEALTH GROUP LLC
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8117900704
    5 BLISTER PACK in 1 PACKAGE (81179-007-04) / 14 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
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": {
    "f863ab35-046b-4006-901e-dd290c164acc": {
      "match": "brand_token",
      "title": "EXPECTORANT GUAIFENESIN EXTENDED-RELEASE (GUAIFENESIN) TABLET [YET HEALTH GROUP LLC]",
      "spl_version": "5",
      "published_date": "2024-01-04"
    }
  },
  "productid": "81179-007_0e127c48-e134-a961-e063-6394a90a3174",
  "productndc": "81179-007",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213420",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "EXPECTORANT GUAIFENESIN EXTENDED-RELEASE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213420",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GUAIFENESIN",
  "start_marketing_date": "20210405",
  "active_numerator_strength": "1200"
}

Related drugs

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