Dextrose And Sodium Chloride

Orange BookUNIISPL

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

Identification

ManufacturerB. Braun Medical Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0264760800
12 CONTAINER in 1 CASE (0264-7608-00) / 1000 mL in 1 CONTAINER
ndc11
0264760810
24 CONTAINER in 1 CASE (0264-7608-10) / 500 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

IY9XDZ35W2

DEXTROSE, UNSPECIFIED FORM

RxCUI 4850

Orange Book

N019631

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": "0264-7608_1e0af1ae-3754-4327-8037-1eb294c86cb6",
  "productndc": "0264-7608",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019631",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5GM/100ML;110MG/100ML",
        "product_no": "001",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5GM/100ML;200MG/100ML",
        "product_no": "002",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5GM/100ML;330MG/100ML",
        "product_no": "003",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5GM/100ML;450MG/100ML",
        "product_no": "004",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5GM/100ML;900MG/100ML",
        "product_no": "005",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;110MG/100ML",
        "product_no": "006",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;200MG/100ML",
        "product_no": "007",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;330MG/100ML",
        "product_no": "008",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;450MG/100ML",
        "product_no": "009",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;900MG/100ML",
        "product_no": "010",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10GM/100ML;110MG/100ML",
        "product_no": "011",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10GM/100ML;200MG/100ML",
        "product_no": "012",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10GM/100ML;330MG/100ML",
        "product_no": "013",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10GM/100ML;450MG/100ML",
        "product_no": "014",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10GM/100ML;900MG/100ML",
        "product_no": "015",
        "approval_date": "Feb 24, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3.3GM/100ML;300MG/100ML",
        "product_no": "016",
        "approval_date": "Jan 19, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE, UNSPECIFIED FORM; SODIUM CHLORIDE",
  "proprietary_name": "Dextrose And Sodium Chloride",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "NDA019631",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE and SODIUM CHLORIDE",
  "start_marketing_date": "19880224",
  "active_numerator_strength": "3.3; .3"
}

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