mannitol

Generic: mannitol

Labeler: icu medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mannitol
Generic Name mannitol
Labeler icu medical inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mannitol 20 g/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-7715
Product ID 0990-7715_b0dfadd1-70b5-49f5-8b63-60d3b4e1cbf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019603
Listing Expiration 2026-12-31
Marketing Start 2019-05-31

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 09907715
Hyphenated Format 0990-7715

Supplemental Identifiers

RxCUI
1791403 1791408
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 NDA019603 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 g/100mL
source: ndc
Packaging
  • 24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12)
  • 12 POUCH in 1 CASE (0990-7715-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13)
source: ndc

Packages (2)

0990-7715-02 24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12) 0990-7715-03 12 POUCH in 1 CASE (0990-7715-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13)

Ingredients (1)

mannitol (20 g/100mL)

Linked Drug Pages (1)

Mannitol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b0dfadd1-70b5-49f5-8b63-60d3b4e1cbf5", "openfda": {"nui": ["N0000175359", "N0000010288", "N0000175810"], "unii": ["3OWL53L36A"], "rxcui": ["1791403", "1791408"], "spl_set_id": ["ba7bf864-8a4d-4262-8fd1-00174fa2f9d1"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Osmotic Diuretic [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["ICU Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CASE (0990-7715-02)  / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12)", "package_ndc": "0990-7715-02", "marketing_start_date": "20190801"}, {"sample": false, "description": "12 POUCH in 1 CASE (0990-7715-03)  / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13)", "package_ndc": "0990-7715-03", "marketing_start_date": "20190531"}], "brand_name": "Mannitol", "product_id": "0990-7715_b0dfadd1-70b5-49f5-8b63-60d3b4e1cbf5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Diuresis [PE]", "Osmotic Activity [MoA]", "Osmotic Diuretic [EPC]"], "product_ndc": "0990-7715", "generic_name": "MANNITOL", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mannitol", "active_ingredients": [{"name": "MANNITOL", "strength": "20 g/100mL"}], "application_number": "NDA019603", "marketing_category": "NDA", "marketing_start_date": "20190531", "listing_expiration_date": "20261231"}