dextrose and sodium chloride

Generic: dextrose monohydrate and sodium chloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextrose and sodium chloride
Generic Name dextrose monohydrate and sodium chloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dextrose monohydrate 5 g/100mL, sodium chloride .9 g/100mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-870
Product ID 63323-870_449bf5b8-ff7c-4d79-a1d2-03886440257d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211211
Listing Expiration 2026-12-31
Marketing Start 2020-10-26

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 63323870
Hyphenated Format 63323-870

Supplemental Identifiers

RxCUI
1795344 1795346
UNII
LX22YL083G 451W47IQ8X

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 ANDA211211 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 g/100mL
  • .9 g/100mL
source: ndc
Packaging
  • 20 BAG in 1 CASE (63323-870-10) / 500 mL in 1 BAG (63323-870-01)
  • 10 BAG in 1 CASE (63323-870-74) / 1000 mL in 1 BAG (63323-870-04)
source: ndc

Packages (2)

63323-870-10 20 BAG in 1 CASE (63323-870-10) / 500 mL in 1 BAG (63323-870-01) 63323-870-74 10 BAG in 1 CASE (63323-870-74) / 1000 mL in 1 BAG (63323-870-04)

Ingredients (2)

dextrose monohydrate (5 g/100mL) sodium chloride (.9 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": "449bf5b8-ff7c-4d79-a1d2-03886440257d", "openfda": {"unii": ["LX22YL083G", "451W47IQ8X"], "rxcui": ["1795344", "1795346"], "spl_set_id": ["68cc9c41-ed24-4f76-8efb-2936ae3ddd8d"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BAG in 1 CASE (63323-870-10)  / 500 mL in 1 BAG (63323-870-01)", "package_ndc": "63323-870-10", "marketing_start_date": "20201026"}, {"sample": false, "description": "10 BAG in 1 CASE (63323-870-74)  / 1000 mL in 1 BAG (63323-870-04)", "package_ndc": "63323-870-74", "marketing_start_date": "20201026"}], "brand_name": "Dextrose and Sodium Chloride", "product_id": "63323-870_449bf5b8-ff7c-4d79-a1d2-03886440257d", "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": "63323-870", "generic_name": "DEXTROSE MONOHYDRATE and SODIUM CHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "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": ".9 g/100mL"}], "application_number": "ANDA211211", "marketing_category": "ANDA", "marketing_start_date": "20201026", "listing_expiration_date": "20261231"}