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United States · US · US:63323-873_e7cba27a-cf18-40d9-986d-29f552d413ff
Dextrose and Sodium Chloride
In shortageOrange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11633238731010 BAG in 1 CASE (63323-873-10) / 1000 mL in 1 BAG
- ndc11633238737420 BAG in 1 CASE (63323-873-74) / 500 mL in 1 BAG
- ndc11633238737530 BAG in 1 CASE (63323-873-75) / 250 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
A211221
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 50% 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": "63323-873_e7cba27a-cf18-40d9-986d-29f552d413ff",
"productndc": "63323-873",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "211221",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5GM/100ML;225MG/100ML",
"product_no": "001",
"approval_date": "Sep 15, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
"shortage_reason": "Dextrose Monohydrate 50% Injection",
"shortage_status": "current",
"proprietary_name": "Dextrose and Sodium Chloride",
"active_ingred_unit": "g/100mL; g/100mL",
"application_number": "ANDA211221",
"marketing_category": "ANDA",
"nonproprietary_name": "DEXTROSE MONOHYDRATE and SODIUM CHLORIDE",
"start_marketing_date": "20201026",
"active_numerator_strength": "5; .225"
}Access this data programmatically
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