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United States · US · US:76457-004_0b586737-4616-db6e-e063-6294a90a6135

SIMPEX Guaifenesin

UNIISPLATC R05CA03

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

Identification

ManufacturerSimpex Pharma Pvt. Ltd
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7645700400
    100 TABLET in 1 CARTON (76457-004-00)

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
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": {
    "1594f9d6-0c48-42bf-b76b-d621f215179a": {
      "match": "brand_token",
      "title": "SIMPEX GUAIFENESIN (GUAIFENESIN) TABLET [SIMPEX PHARMA PVT. LTD]",
      "spl_version": "5",
      "published_date": "2023-12-01"
    }
  },
  "productid": "76457-004_0b586737-4616-db6e-e063-6294a90a6135",
  "productndc": "76457-004",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "SIMPEX Guaifenesin",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "GUAIFENESIN",
  "start_marketing_date": "20180209",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code R05CA03.

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