25% Dextrose Infant

In shortageOrange BookUNIIATC B05CX01

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

Identification

ManufacturerHF Acquisition Co. LLC, DBA Health First

CountryUS (United States)

ATC codeB05CX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166212131
1 SYRINGE, PLASTIC in 1 CARTON (51662-1213-1) / 10 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

N019445

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",
  "productid": "51662-1213_ef6a78fb-553f-a83e-e053-2995a90a6164",
  "productndc": "51662-1213",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019445",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "500MG/ML",
        "product_no": "001",
        "approval_date": "Jun 3, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG/ML",
        "product_no": "002",
        "approval_date": "Nov 23, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE",
  "shortage_reason": "Dextrose Monohydrate 50% Injection",
  "shortage_status": "current",
  "proprietary_name": "25% Dextrose Infant",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019445",
  "marketing_category": "NDA",
  "nonproprietary_name": "25% Dextrose Infant",
  "start_marketing_date": "20180819",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code B05CX01.

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