🇺🇸
United States · US · US:76329-3302_45b366a9-6c0c-4643-9951-4ff880b29c83
Dextrose Monohydrate
In shortageOrange BookUNIISPLATC B05CX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerInternational Medication Systems, Limited
CountryUS (United States)
ATC codeB05CX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176329330211 SYRINGE in 1 CARTON (76329-3302-1) / 50 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
A203451
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": {
"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": "76329-3302_45b366a9-6c0c-4643-9951-4ff880b29c83",
"productndc": "76329-3302",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "203451",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/ML",
"product_no": "001",
"approval_date": "Mar 26, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROSE MONOHYDRATE",
"shortage_reason": "Dextrose Monohydrate 70% Injection",
"shortage_status": "current",
"proprietary_name": "Dextrose Monohydrate",
"active_ingred_unit": "g/50mL",
"application_number": "ANDA203451",
"marketing_category": "ANDA",
"nonproprietary_name": "Dextrose Monohydrate",
"start_marketing_date": "20211111",
"active_numerator_strength": "25"
}Related drugs
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