DEXTROSE

In shortageOrange BookUNIISPLATC B05CX01

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeB05CX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338965175
75 BAG in 1 CARTON (0338-9651-75) / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

N016673

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 70% 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": "0338-9651_66eb82f8-6755-42aa-b20c-192a640e8068",
  "productndc": "0338-9651",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "016673",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "003",
        "approval_date": "Oct 30, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE",
  "shortage_reason": "Dextrose Monohydrate 70% Injection",
  "shortage_status": "current",
  "proprietary_name": "DEXTROSE",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA016673",
  "marketing_category": "NDA",
  "nonproprietary_name": "dextrose monohydrate",
  "start_marketing_date": "19710304",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code B05CX01.

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