🇺🇸
United States · US · US:0404-9844_b6d9ad95-3f05-403d-a0c1-a7ff81d9351b
Infant Dextrose
In shortageOrange BookUNIISPLATC B05CX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeB05CX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104049844101 SYRINGE in 1 BAG (0404-9844-10) / 10 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N019445
AP
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": {
"ce71d929-d11e-444c-bd45-e025d5172057": {
"match": "brand_token",
"title": "INFANT DEXTROSE (DEXTROSE ) INJECTION, SOLUTION [HENRY SCHEIN, INC.]",
"spl_version": "7",
"published_date": "2025-11-17"
}
},
"productid": "0404-9844_b6d9ad95-3f05-403d-a0c1-a7ff81d9351b",
"productndc": "0404-9844",
"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 70% Injection",
"shortage_status": "current",
"proprietary_name": "Infant Dextrose",
"active_ingred_unit": "mg/mL",
"application_number": "NDA019445",
"marketing_category": "NDA",
"nonproprietary_name": "Dextrose",
"start_marketing_date": "20220110",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code B05CX01.
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- 🇪🇸CAPD/DPCA 17 SOLUCION PARA DIALISIS PERITONEALFresenius Medical Care Deutschland Gmbh
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