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United States · US · US:0264-1510_638a41c3-0f07-4d1a-bb4e-1bab16e61266

Dextrose

In shortageOrange BookUNIISPLATC B05CX01

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

Identification

ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeB05CX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0264151031
    84 CONTAINER in 1 CASE (0264-1510-31) / 50 mL in 1 CONTAINER
  • ndc11
    0264151032
    64 CONTAINER in 1 CASE (0264-1510-32) / 100 mL in 1 CONTAINER
  • ndc11
    0264151036
    116 CONTAINER in 1 CASE (0264-1510-36) / 25 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N016730
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": "0264-1510_638a41c3-0f07-4d1a-bb4e-1bab16e61266",
  "productndc": "0264-1510",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "016730",
    "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": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "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": "mg/mL",
  "application_number": "NDA016730",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextrose",
  "start_marketing_date": "19731221",
  "active_numerator_strength": "50"
}

Related drugs

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