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United States · US · US:50090-6813_132e1b7b-c63c-43d3-ac31-8ca034f1210f

Sodium Bicarbonate

In shortageOrange BookUNIISPLATC B05XA02

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeB05XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009068130
    1 VIAL in 1 CARTON (50090-6813-0) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
8MDF5V39QO
SODIUM BICARBONATE
RxCUI 36676
Orange Book
A211091
APAPAPAP
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": "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": "50090-6813_132e1b7b-c63c-43d3-ac31-8ca034f1210f",
  "productndc": "50090-6813",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211091",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "5MEQ/10ML (0.5MEQ/ML)",
        "product_no": "001",
        "approval_date": "Jun 20, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "44.6MEQ/50ML (0.9MEQ/ML)",
        "product_no": "002",
        "approval_date": "Jun 20, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "10MEQ/10ML (1MEQ/ML)",
        "product_no": "003",
        "approval_date": "Jun 20, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "50MEQ/50ML (1MEQ/ML)",
        "product_no": "004",
        "approval_date": "Jun 20, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM BICARBONATE",
  "shortage_reason": "Sodium Oxybate Solution",
  "shortage_status": "current",
  "proprietary_name": "Sodium Bicarbonate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA211091",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM BICARBONATE",
  "start_marketing_date": "20190801",
  "active_numerator_strength": "84"
}

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