dextrose

Generic: dextrose monohydrate

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextrose
Generic Name dextrose monohydrate
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dextrose monohydrate 50 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-460
Product ID 84549-460_3eff8bcd-6a32-428f-e063-6394a90afa68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207449
Listing Expiration 2026-12-31
Marketing Start 2024-07-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549460
Hyphenated Format 84549-460

Supplemental Identifiers

RxCUI
1795607
UNII
LX22YL083G

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
  • 500 mL in 1 BAG (84549-460-20)
source: ndc

Packages (1)

84549-460-20 500 mL in 1 BAG (84549-460-20)

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": "3eff8bcd-6a32-428f-e063-6394a90afa68", "openfda": {"unii": ["LX22YL083G"], "rxcui": ["1795607"], "spl_set_id": ["3eff8bcd-6a33-428f-e063-6394a90afa68"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BAG (84549-460-20)", "package_ndc": "84549-460-20", "marketing_start_date": "20250917"}], "brand_name": "Dextrose", "product_id": "84549-460_3eff8bcd-6a32-428f-e063-6394a90afa68", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "84549-460", "generic_name": "Dextrose Monohydrate", "labeler_name": "ProPharma Distribution", "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": "20240709", "listing_expiration_date": "20261231"}