Dextrose

In shortageOrange BookUNIISPLATC B05CX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBaxter Healthcare Company

CountryUS (United States)

ATC codeB05CX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338966440
40 BAG in 1 CARTON (0338-9664-40) / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

N020179

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 5% 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": "0338-9664_bfc4224a-2fc9-4137-b4c6-9d2d6d948413",
  "productndc": "0338-9664",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020179",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "001",
        "approval_date": "Dec 7, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "002",
        "approval_date": "Dec 7, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE",
  "shortage_reason": "Dextrose Monohydrate 5% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA020179",
  "marketing_category": "NDA",
  "nonproprietary_name": "dextrose monohydrate",
  "start_marketing_date": "19921207",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code B05CX01.

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