Sodium Bicarbonate

In shortageOrange BookUNIISPLATC B05XA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerExela Pharma Sciences, LLC

CountryUS (United States)

ATC codeB05XA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5175450014
25 VIAL in 1 CARTON (51754-5001-4) / 50 mL in 1 VIAL
ndc11
5175450015
20 VIAL in 1 CARTON (51754-5001-5) / 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 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": "51754-5001_4da0ba66-756d-4b4d-8018-81ca16578ef1",
  "productndc": "51754-5001",
  "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 Chloride 0.9% Injection",
  "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"
}

Related drugs

Other records sharing ATC code B05XA02.

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