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United States · US · US:0404-9847_dc1905f1-fbdd-4bf8-8568-4d4d7c6abd59

Dextrose

In shortageOrange BookUNIISPLATC B05CX01

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

Identification

ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeB05CX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0404984750
    1 VIAL, SINGLE-DOSE in 1 BAG (0404-9847-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N019445
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": "0404-9847_dc1905f1-fbdd-4bf8-8568-4d4d7c6abd59",
  "productndc": "0404-9847",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019445",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "500MG/ML",
        "product_no": "001",
        "approval_date": "Jun 3, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG/ML",
        "product_no": "002",
        "approval_date": "Nov 23, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE",
  "shortage_reason": "Dextrose Monohydrate 50% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA019445",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextrose Monohydrate",
  "start_marketing_date": "20220110",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code B05CX01.

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