🇺🇸
United States · US · US:63323-624_40c07bed-7ccc-4117-a595-78c2a053e8a9
Dextrose
In shortageOrange BookUNIISPLATC B05CX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB05CX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11633236241010 BAG in 1 CASE (63323-624-10) / 1000 mL in 1 BAG (63323-624-03)
- ndc11633236245060 BAG in 1 CASE (63323-624-50) / 50 mL in 1 BAG (63323-624-05)
- ndc11633236246150 BAG in 1 CASE (63323-624-61) / 100 mL in 1 BAG (63323-624-06)
- ndc11633236247430 BAG in 1 CASE (63323-624-74) / 250 mL in 1 BAG (63323-624-04)
- ndc11633236247520 BAG in 1 CASE (63323-624-75) / 500 mL in 1 BAG (63323-624-07)
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
A207449
AP
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": "63323-624_40c07bed-7ccc-4117-a595-78c2a053e8a9",
"productndc": "63323-624",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207449",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Oct 21, 2016"
}
],
"appl_type": "A"
},
"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": "mg/mL",
"application_number": "ANDA207449",
"marketing_category": "ANDA",
"nonproprietary_name": "Dextrose Monohydrate",
"start_marketing_date": "20161021",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code B05CX01.
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- GBAddGluco Glucose powderTriOn Pharma Ltd
- 🇪🇸CAPD/DPCA 17 SOLUCION PARA DIALISIS PERITONEALFresenius Medical Care Deutschland Gmbh
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