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United States · US · US:0338-9147_539f43d0-ac05-4261-a87d-8b34b07e0dd7

Dextrose

In shortageOrange BookUNIISPLATC B05CX01

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

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
    0338914730
    30 BAG in 1 CARTON (0338-9147-30) / 100 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 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": "0338-9147_539f43d0-ac05-4261-a87d-8b34b07e0dd7",
  "productndc": "0338-9147",
  "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 70% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA020179",
  "marketing_category": "NDA",
  "nonproprietary_name": "dextrose monohydrate",
  "start_marketing_date": "19921207",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code B05CX01.

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