DEXTROSE

Orange BookUNIISPLATC 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 · 3

ndc11
0264752000
12 CONTAINER in 1 CASE (0264-7520-00) / 1000 mL in 1 CONTAINER
ndc11
0264752010
24 CONTAINER in 1 CASE (0264-7520-10) / 500 mL in 1 CONTAINER
ndc11
0264752020
24 CONTAINER in 1 CASE (0264-7520-20) / 250 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

IY9XDZ35W2

DEXTROSE, UNSPECIFIED FORM

RxCUI 4850

Orange Book

N019626

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IY9XDZ35W2",
    "rxcui": "4850",
    "inchikey": null,
    "display_name": "DEXTROSE, UNSPECIFIED FORM",
    "substance_type": "mixture",
    "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": "0264-7520_c9f87749-8dd5-41fd-b393-f63d45fd00ef",
  "productndc": "0264-7520",
  "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, UNSPECIFIED FORM",
  "proprietary_name": "DEXTROSE",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA019626",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE",
  "start_marketing_date": "19880202",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code B05CX01.

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