Dextrose

In shortageOrange BookSPLATC B05CX01

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

Identification

ManufacturerB. Braun Medical Inc.

CountryUS (United States)

ATC codeB05CX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0264738750
4 CONTAINER in 1 CASE (0264-7387-50) / 2000 mL in 1 CONTAINER

Annotations

Orange Book

N019626

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 70% Injection

Raw payload (JSON)

{
  "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": "0264-7387_200c4b9e-283a-4dea-b33a-9bb4936b2b99",
  "productndc": "0264-7387",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "019626",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5GM/100ML",
        "product_no": "001",
        "approval_date": "Feb 2, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "002",
        "approval_date": "Feb 2, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7.7GM/100ML",
        "product_no": "003",
        "approval_date": "Feb 2, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10GM/100ML",
        "product_no": "004",
        "approval_date": "Feb 2, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "70GM/100ML",
        "product_no": "005",
        "approval_date": "Feb 18, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE",
  "shortage_reason": "Dextrose Monohydrate 70% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA019626",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextrose",
  "start_marketing_date": "20150219",
  "active_numerator_strength": "70"
}

Related drugs

Other records sharing ATC code B05CX01.

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