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United States · US · US:0338-0077_b4404498-6ab7-4c25-a5a2-5377a6dfecca
Dextrose and Sodium Chloride
In shortageOrange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Company
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11033800770236 BAG in 1 CARTON (0338-0077-02) / 250 mL in 1 BAG
- ndc11033800770414 BAG in 1 CARTON (0338-0077-04) / 1000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N016689
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": "0338-0077_b4404498-6ab7-4c25-a5a2-5377a6dfecca",
"productndc": "0338-0077",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "016689",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5GM/100ML;200MG/100ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"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; mg/100mL",
"application_number": "NDA016689",
"marketing_category": "NDA",
"nonproprietary_name": "Dextrose and Sodium Chloride",
"start_marketing_date": "19701208",
"active_numerator_strength": "5; 200"
}Access this data programmatically
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