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United States · US · US:68462-951_f38d0dfc-9bcc-4224-a202-885c9ad0beae

SODIUM BICARBONATE

In shortageOrange BookUNIISPLATC B05XA02

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeB05XA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6846295165
    25 VIAL in 1 CARTON (68462-951-65) / 50 mL in 1 VIAL (68462-951-50)

Annotations

UNII (FDA Substance ID)
8MDF5V39QO
SODIUM BICARBONATE
RxCUI 36676
Orange Book
A219701
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": "68462-951_f38d0dfc-9bcc-4224-a202-885c9ad0beae",
  "productndc": "68462-951",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219701",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MEQ/50ML (1MEQ/ML)",
        "product_no": "001",
        "approval_date": "Jun 26, 2025"
      }
    ],
    "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": "ANDA219701",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM BICARBONATE",
  "start_marketing_date": "20250807",
  "active_numerator_strength": "84"
}

Related drugs

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