dextrose

Generic: dextrose monohydrate

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

Drug Facts

Product Profile

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

dextrose monohydrate 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-624
Product ID 63323-624_40c07bed-7ccc-4117-a595-78c2a053e8a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207449
Listing Expiration 2026-12-31
Marketing Start 2016-10-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323624
Hyphenated Format 63323-624

Supplemental Identifiers

RxCUI
1795607 1795609 1795610 1795612 1795616
UNII
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 (source: ndc)
Generic Name dextrose monohydrate (source: ndc)
Application Number ANDA207449 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CASE (63323-624-10) / 1000 mL in 1 BAG (63323-624-03)
  • 60 BAG in 1 CASE (63323-624-50) / 50 mL in 1 BAG (63323-624-05)
  • 50 BAG in 1 CASE (63323-624-61) / 100 mL in 1 BAG (63323-624-06)
  • 30 BAG in 1 CASE (63323-624-74) / 250 mL in 1 BAG (63323-624-04)
  • 20 BAG in 1 CASE (63323-624-75) / 500 mL in 1 BAG (63323-624-07)
source: ndc

Packages (5)

63323-624-10 10 BAG in 1 CASE (63323-624-10) / 1000 mL in 1 BAG (63323-624-03) 63323-624-50 60 BAG in 1 CASE (63323-624-50) / 50 mL in 1 BAG (63323-624-05) 63323-624-61 50 BAG in 1 CASE (63323-624-61) / 100 mL in 1 BAG (63323-624-06) 63323-624-74 30 BAG in 1 CASE (63323-624-74) / 250 mL in 1 BAG (63323-624-04) 63323-624-75 20 BAG in 1 CASE (63323-624-75) / 500 mL in 1 BAG (63323-624-07)

Ingredients (1)

dextrose monohydrate (50 mg/mL)

Linked Drug Pages (1)

Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "40c07bed-7ccc-4117-a595-78c2a053e8a9", "openfda": {"unii": ["LX22YL083G"], "rxcui": ["1795607", "1795609", "1795610", "1795612", "1795616"], "spl_set_id": ["f2379398-a07b-417e-a022-f7b41f962067"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CASE (63323-624-10)  / 1000 mL in 1 BAG (63323-624-03)", "package_ndc": "63323-624-10", "marketing_start_date": "20161021"}, {"sample": false, "description": "60 BAG in 1 CASE (63323-624-50)  / 50 mL in 1 BAG (63323-624-05)", "package_ndc": "63323-624-50", "marketing_start_date": "20180731"}, {"sample": false, "description": "50 BAG in 1 CASE (63323-624-61)  / 100 mL in 1 BAG (63323-624-06)", "package_ndc": "63323-624-61", "marketing_start_date": "20161021"}, {"sample": false, "description": "30 BAG in 1 CASE (63323-624-74)  / 250 mL in 1 BAG (63323-624-04)", "package_ndc": "63323-624-74", "marketing_start_date": "20161021"}, {"sample": false, "description": "20 BAG in 1 CASE (63323-624-75)  / 500 mL in 1 BAG (63323-624-07)", "package_ndc": "63323-624-75", "marketing_start_date": "20161021"}], "brand_name": "Dextrose", "product_id": "63323-624_40c07bed-7ccc-4117-a595-78c2a053e8a9", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63323-624", "generic_name": "Dextrose Monohydrate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextrose", "active_ingredients": [{"name": "DEXTROSE MONOHYDRATE", "strength": "50 mg/mL"}], "application_number": "ANDA207449", "marketing_category": "ANDA", "marketing_start_date": "20161021", "listing_expiration_date": "20261231"}