dextrose and sodium chloride

Generic: dextrose monohydrate and sodium chloride

Labeler: icu medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextrose and sodium chloride
Generic Name dextrose monohydrate and sodium chloride
Labeler icu medical inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dextrose monohydrate 5 g/100mL, sodium chloride .3 g/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-7925
Product ID 0990-7925_391a9854-64db-4da4-b8a5-a230001aa81c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017799
Listing Expiration 2026-12-31
Marketing Start 2019-09-01

Pharmacologic Class

Classes
increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] osmotic activity [moa] osmotic laxative [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09907925
Hyphenated Format 0990-7925

Supplemental Identifiers

RxCUI
1794902 1794904 1794905 1795149 1795150 1795250 1795252 1795254 1795344 1795346
UNII
451W47IQ8X LX22YL083G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dextrose and sodium chloride (source: ndc)
Generic Name dextrose monohydrate and sodium chloride (source: ndc)
Application Number NDA017799 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 g/100mL
  • .3 g/100mL
source: ndc
Packaging
  • 24 POUCH in 1 CASE (0990-7925-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG
  • 12 POUCH in 1 CASE (0990-7925-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
source: ndc

Packages (2)

0990-7925-03 24 POUCH in 1 CASE (0990-7925-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG 0990-7925-09 12 POUCH in 1 CASE (0990-7925-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Ingredients (2)

dextrose monohydrate (5 g/100mL) sodium chloride (.3 g/100mL)

Linked Drug Pages (1)

Dextrose and Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "391a9854-64db-4da4-b8a5-a230001aa81c", "openfda": {"unii": ["451W47IQ8X", "LX22YL083G"], "rxcui": ["1794902", "1794904", "1794905", "1795149", "1795150", "1795250", "1795252", "1795254", "1795344", "1795346"], "spl_set_id": ["4555b1bf-6d97-4798-a63d-6d34291c85ce"], "manufacturer_name": ["ICU Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CASE (0990-7925-03)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG", "package_ndc": "0990-7925-03", "marketing_start_date": "20191125"}, {"sample": false, "description": "12 POUCH in 1 CASE (0990-7925-09)  / 1 BAG in 1 POUCH / 1000 mL in 1 BAG", "package_ndc": "0990-7925-09", "marketing_start_date": "20191201"}], "brand_name": "Dextrose and Sodium Chloride", "product_id": "0990-7925_391a9854-64db-4da4-b8a5-a230001aa81c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]"], "product_ndc": "0990-7925", "generic_name": "DEXTROSE MONOHYDRATE and SODIUM CHLORIDE", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextrose and Sodium Chloride", "active_ingredients": [{"name": "DEXTROSE MONOHYDRATE", "strength": "5 g/100mL"}, {"name": "SODIUM CHLORIDE", "strength": ".3 g/100mL"}], "application_number": "NDA017799", "marketing_category": "NDA", "marketing_start_date": "20190901", "listing_expiration_date": "20261231"}