Dextrose and Sodium Chloride

In shortageOrange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6332386910
10 BAG in 1 CASE (63323-869-10) / 1000 mL in 1 BAG (63323-869-01)
ndc11
6332386974
20 BAG in 1 CASE (63323-869-74) / 500 mL in 1 BAG (63323-869-04)
ndc11
6332386975
30 BAG in 1 CASE (63323-869-75) / 250 mL in 1 BAG (63323-869-05)

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

A211276

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 50% 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": "63323-869_07c0fcbe-d4e6-4c20-b72c-5c217abafd7d",
  "productndc": "63323-869",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211276",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;450MG/100ML",
        "product_no": "001",
        "approval_date": "Sep 15, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 50% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "ANDA211276",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE and SODIUM CHLORIDE",
  "start_marketing_date": "20201026",
  "active_numerator_strength": "5; .45"
}

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