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United States · US · US:81665-200_ada1be4a-11f4-4850-b98c-88e6ef02cd31

Sodium Bicarbonate

In shortageOrange BookUNIISPLATC B05XA02

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

Identification

ManufacturerOMNIVIUM PHARMACEUTICALS LLC.
CountryUS (United States)
ATC codeB05XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8166520005
    20 VIAL in 1 CARTON (81665-200-05) / 50 mL in 1 VIAL (81665-200-01)
  • ndc11
    8166520025
    25 VIAL in 1 CARTON (81665-200-25) / 50 mL in 1 VIAL (81665-200-01)

Annotations

UNII (FDA Substance ID)
8MDF5V39QO
SODIUM BICARBONATE
RxCUI 36676
Orange Book
A216364
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "8MDF5V39QO",
    "rxcui": "36676",
    "inchikey": "UIIMBOGNXHQVGW-UHFFFAOYSA-M",
    "display_name": "SODIUM BICARBONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52430b12-4d5f-d1e1-e063-6394a90abd64": {
      "match": "brand_token",
      "title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "81665-200_ada1be4a-11f4-4850-b98c-88e6ef02cd31",
  "productndc": "81665-200",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216364",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MEQ/50ML (1MEQ/ML)",
        "product_no": "001",
        "approval_date": "Jun 15, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM BICARBONATE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Bicarbonate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216364",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM BICARBONATE",
  "start_marketing_date": "20230616",
  "active_numerator_strength": "84"
}

Related drugs

Other records sharing ATC code B05XA02.

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