osmitrol

Generic: mannitol

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name osmitrol
Generic Name mannitol
Labeler baxter healthcare company
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mannitol 20 g/100mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-0357
Product ID 0338-0357_3911fd42-2b73-4509-9c4c-92ceba4e6d34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA013684
Listing Expiration 2026-12-31
Marketing Start 1964-06-08

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 03380357
Hyphenated Format 0338-0357

Supplemental Identifiers

RxCUI
206536 1791395 1791403 1791404 1791408 1791409
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 osmitrol (source: ndc)
Generic Name mannitol (source: ndc)
Application Number NDA013684 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 g/100mL
source: ndc
Packaging
  • 250 mL in 1 BAG (0338-0357-02)
  • 500 mL in 1 BAG (0338-0357-03)
source: ndc

Packages (2)

0338-0357-02 250 mL in 1 BAG (0338-0357-02) 0338-0357-03 500 mL in 1 BAG (0338-0357-03)

Ingredients (1)

mannitol (20 g/100mL)

Linked Drug Pages (1)

Osmitrol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3911fd42-2b73-4509-9c4c-92ceba4e6d34", "openfda": {"nui": ["N0000175359", "N0000010288", "N0000175810"], "unii": ["3OWL53L36A"], "rxcui": ["206536", "1791395", "1791403", "1791404", "1791408", "1791409"], "spl_set_id": ["0d914965-7001-45cb-ba51-d7c5964b05bc"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Osmotic Diuretic [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BAG (0338-0357-02)", "package_ndc": "0338-0357-02", "marketing_start_date": "19640608"}, {"sample": false, "description": "500 mL in 1 BAG (0338-0357-03)", "package_ndc": "0338-0357-03", "marketing_start_date": "19640608"}], "brand_name": "Osmitrol", "product_id": "0338-0357_3911fd42-2b73-4509-9c4c-92ceba4e6d34", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Diuresis [PE]", "Osmotic Activity [MoA]", "Osmotic Diuretic [EPC]"], "product_ndc": "0338-0357", "generic_name": "Mannitol", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Osmitrol", "active_ingredients": [{"name": "MANNITOL", "strength": "20 g/100mL"}], "application_number": "NDA013684", "marketing_category": "NDA", "marketing_start_date": "19640608", "listing_expiration_date": "20261231"}