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United States · US · US:61649-733_124a286a-fd2a-6d1d-e063-6294a90a6c18

BIO SPECTRA

In shortageUNIISPLATC C03CB

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

Identification

Manufacturer9055-7588 Quebec Inc. DBA Attitude
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6164973301
    120 g in 1 TUBE (61649-733-01)

Annotations

UNII (FDA Substance ID)
RU45X2JN0Z
POTASSIUM NITRATE
RxCUI 34316
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Citrate Tablet, Extended Release
Raw payload (JSON)
{
  "unii": {
    "unii": "RU45X2JN0Z",
    "rxcui": "34316",
    "inchikey": "FGIUAXJPYTZDNR-UHFFFAOYSA-N",
    "display_name": "POTASSIUM NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "DENTAL",
  "spl_meta": {
    "63ba282e-7293-459a-8921-79a2b9e89e29": {
      "match": "brand_token",
      "title": "BIO CLEMATIS (CLEMATIS VITALBA FLOWER) LIQUID [BIOACTIVE NUTRITIONAL, INC.]",
      "spl_version": "4",
      "published_date": "2026-04-28"
    }
  },
  "productid": "61649-733_124a286a-fd2a-6d1d-e063-6294a90a6c18",
  "productndc": "61649-733",
  "dosage_form": "PASTE, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
  "shortage_reason": "Potassium Citrate Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "BIO SPECTRA",
  "active_ingred_unit": "g/100g; g/100g",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Sodium fluoride and Potassium nitrate",
  "start_marketing_date": "20240426",
  "active_numerator_strength": "5; .243"
}

Related drugs

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