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United States · US · US:52083-683_cb33b7c4-d41e-450e-b731-77fc4f8e1720

G-DOLOGEN

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerKramer Novis
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5208368390
    90 TABLET in 1 BOTTLE, PLASTIC (52083-683-90)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7a4e1d64-2510-405f-a1dc-e02a803b6fbd": {
      "match": "brand_token",
      "title": "G-DOLOGEN (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [KRAMER NOVIS]",
      "spl_version": "1",
      "published_date": "2025-12-25"
    }
  },
  "productid": "52083-683_cb33b7c4-d41e-450e-b731-77fc4f8e1720",
  "productndc": "52083-683",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "G-DOLOGEN",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dexbrompheniramine maleate",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "500; 2"
}

Related drugs

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