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United States · US · US:65131-097_54539b4d-eb99-4198-8486-bfac15605c04

BRONCOCHEM

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerLABORATORIO MAGNACHEM INTERNATIONAL SRL
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6513109712
    25 PACKAGE in 1 BOX (65131-097-12) / 13 g in 1 PACKAGE (65131-097-52)
  • ndc11
    6513109753
    6 PACKAGE in 1 BOX (65131-097-53) / 13 g in 1 PACKAGE (65131-097-52)

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": {
    "dffdfa2c-a52e-4606-9b07-c8993e499f09": {
      "match": "brand_token",
      "title": "BRONCOCHEM MAXIMUM COUGH NIGHT (DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]",
      "spl_version": "1",
      "published_date": "2025-04-21"
    }
  },
  "productid": "65131-097_54539b4d-eb99-4198-8486-bfac15605c04",
  "productndc": "65131-097",
  "dosage_form": "GRANULE, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "BRONCOCHEM",
  "active_ingred_unit": "mg/13g; mg/13g",
  "application_number": "M",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE",
  "start_marketing_date": "20130901",
  "active_numerator_strength": "500; 4"
}

Related drugs

Other records sharing ATC code N02BE.

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