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United States · US · US:0338-0017_31bb4a5f-733e-4354-9fbf-138dede4db0f

DEXTROSE

In shortageOrange BookUNIISPLATC B05CX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeB05CX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    0338001702
    250 mL in 1 BAG (0338-0017-02)
  • ndc11
    0338001703
    500 mL in 1 BAG (0338-0017-03)
  • ndc11
    0338001704
    1000 mL in 1 BAG (0338-0017-04)
  • ndc11
    0338001710
    4 BAG in 1 POUCH (0338-0017-10) / 25 mL in 1 BAG
  • ndc11
    0338001711
    4 BAG in 1 POUCH (0338-0017-11) / 50 mL in 1 BAG
  • ndc11
    0338001718
    4 BAG in 1 POUCH (0338-0017-18) / 100 mL in 1 BAG
  • ndc11
    0338001731
    16 BAG in 1 POUCH (0338-0017-31) / 50 mL in 1 BAG
  • ndc11
    0338001738
    16 BAG in 1 POUCH (0338-0017-38) / 100 mL in 1 BAG
  • ndc11
    0338001741
    1 BAG in 1 PACKAGE (0338-0017-41) / 50 mL in 1 BAG
  • ndc11
    0338001748
    1 BAG in 1 PACKAGE (0338-0017-48) / 100 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N016673
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 70% 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": "0338-0017_31bb4a5f-733e-4354-9fbf-138dede4db0f",
  "productndc": "0338-0017",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "016673",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "003",
        "approval_date": "Oct 30, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE",
  "shortage_reason": "Dextrose Monohydrate 70% Injection",
  "shortage_status": "current",
  "proprietary_name": "DEXTROSE",
  "active_ingred_unit": "g/1000mL",
  "application_number": "NDA016673",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE",
  "start_marketing_date": "19710304",
  "active_numerator_strength": "50"
}

Related drugs

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