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
6332386710
10 BAG in 1 CASE (63323-867-10) / 1000 mL in 1 BAG
ndc11
6332386774
20 BAG in 1 CASE (63323-867-74) / 500 mL in 1 BAG
ndc11
6332386775
30 BAG in 1 CASE (63323-867-75) / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

A211194

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 5% 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": "63323-867_ee6bbc93-9dcb-4d7f-afe3-4588b0566d15",
  "productndc": "63323-867",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211194",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;300MG/100ML",
        "product_no": "001",
        "approval_date": "Aug 26, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 5% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "ANDA211194",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE and SODIUM CHLORIDE",
  "start_marketing_date": "20201026",
  "active_numerator_strength": "5; .3"
}

Access this data programmatically

Query Dextrose and Sodium Chloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs