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United States · US · US:65219-236_39549d47-5040-4b1f-8b46-f0dd95832e1e

Dextrose

In shortageOrange BookUNIISPLATC B05CX01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB05CX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521923610
    50 BAG in 1 CASE (65219-236-10) / 100 mL in 1 BAG (65219-236-01)

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
A207449
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 10% 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": "65219-236_39549d47-5040-4b1f-8b46-f0dd95832e1e",
  "productndc": "65219-236",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207449",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Oct 21, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE",
  "shortage_reason": "Dextrose Monohydrate 10% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose",
  "active_ingred_unit": "mg/100mL",
  "application_number": "ANDA207449",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextrose Monohydrate",
  "start_marketing_date": "20161021",
  "active_numerator_strength": "5000"
}

Related drugs

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