dextrose monohydrate

Generic: dextrose monohydrate

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextrose monohydrate
Generic Name dextrose monohydrate
Labeler international medication systems, limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dextrose monohydrate 25 g/50mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-3302
Product ID 76329-3302_45b366a9-6c0c-4643-9951-4ff880b29c83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203451
Listing Expiration 2026-12-31
Marketing Start 2021-11-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763293302
Hyphenated Format 76329-3302

Supplemental Identifiers

RxCUI
727517
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 monohydrate (source: ndc)
Generic Name dextrose monohydrate (source: ndc)
Application Number ANDA203451 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 g/50mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (76329-3302-1) / 50 mL in 1 SYRINGE
source: ndc

Packages (1)

76329-3302-1 1 SYRINGE in 1 CARTON (76329-3302-1) / 50 mL in 1 SYRINGE

Ingredients (1)

dextrose monohydrate (25 g/50mL)

Linked Drug Pages (1)

Dextrose Monohydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "45b366a9-6c0c-4643-9951-4ff880b29c83", "openfda": {"unii": ["LX22YL083G"], "rxcui": ["727517"], "spl_set_id": ["fcc7ac79-cd70-4f03-a4de-f051f9ca1f7d"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (76329-3302-1)  / 50 mL in 1 SYRINGE", "package_ndc": "76329-3302-1", "marketing_start_date": "20211111"}], "brand_name": "Dextrose Monohydrate", "product_id": "76329-3302_45b366a9-6c0c-4643-9951-4ff880b29c83", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "76329-3302", "generic_name": "Dextrose Monohydrate", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextrose Monohydrate", "active_ingredients": [{"name": "DEXTROSE MONOHYDRATE", "strength": "25 g/50mL"}], "application_number": "ANDA203451", "marketing_category": "ANDA", "marketing_start_date": "20211111", "listing_expiration_date": "20261231"}