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United States · US · US:81943-503_434867f7-9e51-1f4e-e063-6394a90a641d

QUABIC-100

In shortageUNIISPLATC B05XA02

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

Identification

ManufacturerAqua Medica, S.A. de C.V.
CountryUS (United States)
ATC codeB05XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8194350302
    650 mL in 1 BOTTLE (81943-503-02)

Annotations

UNII (FDA Substance ID)
8MDF5V39QO
SODIUM BICARBONATE
RxCUI 36676
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Oxybate Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "8MDF5V39QO",
    "rxcui": "36676",
    "inchikey": "UIIMBOGNXHQVGW-UHFFFAOYSA-M",
    "display_name": "SODIUM BICARBONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "HEMODIALYSIS",
  "spl_meta": {
    "28152c9f-b15c-3707-e063-6394a90a70e9": {
      "match": "brand_token",
      "title": "QUABIC-100 (HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION) SOLUTION, CONCENTRATE [AQUA MEDICA, S.A. DE C.V.]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "81943-503_434867f7-9e51-1f4e-e063-6394a90a641d",
  "productndc": "81943-503",
  "dosage_form": "SOLUTION, CONCENTRATE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "SODIUM BICARBONATE",
  "shortage_reason": "Sodium Oxybate Solution",
  "shortage_status": "current",
  "proprietary_name": "QUABIC-100",
  "active_ingred_unit": "g/100mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER",
  "nonproprietary_name": "Hemodialysis Grade Sodium Bicarbonate Solution",
  "start_marketing_date": "20200330",
  "active_numerator_strength": "8.4"
}

Related drugs

Other records sharing ATC code B05XA02.

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