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United States · US · US:51662-1383_12043b74-781d-390e-e063-6394a90a062b

SODIUM BICARBONATE

In shortageOrange BookUNIISPLATC B05XA02

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeB05XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166213831
    1 SYRINGE in 1 CARTON (51662-1383-1) / 50 mL in 1 SYRINGE
  • ndc11
    5166213833
    10 POUCH in 1 CASE (51662-1383-3) / 1 SYRINGE in 1 POUCH (51662-1383-2) / 50 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
8MDF5V39QO
SODIUM BICARBONATE
RxCUI 36676
Orange Book
A203449
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate 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": "51662-1383_12043b74-781d-390e-e063-6394a90a062b",
  "productndc": "51662-1383",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203449",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MEQ/50ML (1MEQ/ML)",
        "product_no": "001",
        "approval_date": "Sep 19, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM BICARBONATE",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "SODIUM BICARBONATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203449",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM BICARBONATE",
  "start_marketing_date": "20200518",
  "active_numerator_strength": "84"
}

Related drugs

Other records sharing ATC code B05XA02.

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