🇺🇸
United States · US · US:0338-0719_aa64f648-e931-4a99-9b81-791a3827272c
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 · 1
- ndc1103380719062000 mL in 1 BAG (0338-0719-06)
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N020047
APAP
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": "0338-0719_aa64f648-e931-4a99-9b81-791a3827272c",
"productndc": "0338-0719",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "020047",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "50GM/100ML",
"product_no": "001",
"approval_date": "Jul 2, 1991"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60GM/100ML",
"product_no": "002",
"approval_date": "Jul 2, 1991"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "70GM/100ML",
"product_no": "003",
"approval_date": "Jul 2, 1991"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROSE MONOHYDRATE",
"shortage_reason": "Dextrose Monohydrate 5% Injection",
"shortage_status": "current",
"proprietary_name": "DEXTROSE",
"active_ingred_unit": "g/100mL",
"application_number": "NDA020047",
"marketing_category": "NDA",
"nonproprietary_name": "Dextrose monohydrate",
"start_marketing_date": "19910702",
"active_numerator_strength": "70"
}Related drugs
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