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United States · US · US:63323-873_e7cba27a-cf18-40d9-986d-29f552d413ff

Dextrose and Sodium Chloride

In shortageOrange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6332387310
    10 BAG in 1 CASE (63323-873-10) / 1000 mL in 1 BAG
  • ndc11
    6332387374
    20 BAG in 1 CASE (63323-873-74) / 500 mL in 1 BAG
  • ndc11
    6332387375
    30 BAG in 1 CASE (63323-873-75) / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
A211221
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 50% Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "LX22YL083G",
    "rxcui": "1299920",
    "inchikey": "SPFMQWBKVUQXJV-BTVCFUMJSA-N",
    "display_name": "DEXTROSE MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "60b6d7c3-0164-46c9-aa38-b5aa1c31a5d5": {
      "match": "brand_token",
      "title": "DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]",
      "spl_version": "11",
      "published_date": "2026-05-25"
    }
  },
  "productid": "63323-873_e7cba27a-cf18-40d9-986d-29f552d413ff",
  "productndc": "63323-873",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211221",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;225MG/100ML",
        "product_no": "001",
        "approval_date": "Sep 15, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 50% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "ANDA211221",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE and SODIUM CHLORIDE",
  "start_marketing_date": "20201026",
  "active_numerator_strength": "5; .225"
}

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