mannitol

Generic: mannitol

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

Drug Facts

Product Profile

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

mannitol 250 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-024
Product ID 63323-024_fe8beed4-a8db-400e-834e-b5efe2f5af1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080677
Listing Expiration 2026-12-31
Marketing Start 2000-03-19

Pharmacologic Class

Established (EPC)
osmotic diuretic [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323024
Hyphenated Format 63323-024

Supplemental Identifiers

RxCUI
311450
UPC
0363323024017
UNII
3OWL53L36A
NUI
N0000175359 N0000010288 N0000175810

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 mannitol (source: ndc)
Generic Name mannitol (source: ndc)
Application Number ANDA080677 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01)
source: ndc

Packages (1)

63323-024-25 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01)

Ingredients (1)

mannitol (250 mg/mL)

Linked Drug Pages (1)

Mannitol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fe8beed4-a8db-400e-834e-b5efe2f5af1c", "openfda": {"nui": ["N0000175359", "N0000010288", "N0000175810"], "upc": ["0363323024017"], "unii": ["3OWL53L36A"], "rxcui": ["311450"], "spl_set_id": ["c395e13d-6ea1-4104-8b37-669cfb982f04"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Osmotic Diuretic [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25)  / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01)", "package_ndc": "63323-024-25", "marketing_start_date": "20000319"}], "brand_name": "Mannitol", "product_id": "63323-024_fe8beed4-a8db-400e-834e-b5efe2f5af1c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Diuresis [PE]", "Osmotic Activity [MoA]", "Osmotic Diuretic [EPC]"], "product_ndc": "63323-024", "generic_name": "MANNITOL", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mannitol", "active_ingredients": [{"name": "MANNITOL", "strength": "250 mg/mL"}], "application_number": "ANDA080677", "marketing_category": "ANDA", "marketing_start_date": "20000319", "listing_expiration_date": "20261231"}