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United States · US · US:52083-632_c3363889-6ee4-4e45-9233-712513223055

Presgen

UNIISPLATC R05DA

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

Identification

ManufacturerKramer Novis
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5208363216
    480 mL in 1 BOTTLE (52083-632-16)

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
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": {
    "5befa829-32bd-4978-8a0e-1d6513ff37a4": {
      "match": "brand_token",
      "title": "PRESGEN B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]",
      "spl_version": "5",
      "published_date": "2025-12-12"
    }
  },
  "productid": "52083-632_c3363889-6ee4-4e45-9233-712513223055",
  "productndc": "52083-632",
  "dosage_form": "SYRUP",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Presgen",
  "active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide",
  "start_marketing_date": "20110328",
  "active_numerator_strength": "10; 200; 5"
}

Related drugs

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