sorbitol-mannitol

Generic: sorbitol and mannitol

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

Drug Facts

Product Profile

Brand Name sorbitol-mannitol
Generic Name sorbitol and mannitol
Labeler icu medical inc.
Dosage Form IRRIGANT
Routes
URETHRAL
Active Ingredients

mannitol .54 g/100mL, sorbitol 2.7 g/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-7981
Product ID 0990-7981_dda87a72-d2a8-41f8-8d73-52931a149dc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018316
Listing Expiration 2026-12-31
Marketing Start 2019-10-01

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 09907981
Hyphenated Format 0990-7981

Supplemental Identifiers

RxCUI
311446
UNII
3OWL53L36A 506T60A25R
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 sorbitol-mannitol (source: ndc)
Generic Name sorbitol and mannitol (source: ndc)
Application Number NDA018316 (source: ndc)
Routes
URETHRAL
source: ndc

Resolved Composition

Strengths
  • .54 g/100mL
  • 2.7 g/100mL
source: ndc
Packaging
  • 4 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG
source: ndc

Packages (1)

0990-7981-08 4 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG

Ingredients (2)

mannitol (.54 g/100mL) sorbitol (2.7 g/100mL)

Linked Drug Pages (1)

Sorbitol-Mannitol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["URETHRAL"], "spl_id": "dda87a72-d2a8-41f8-8d73-52931a149dc0", "openfda": {"nui": ["N0000175359", "N0000010288", "N0000175810"], "unii": ["3OWL53L36A", "506T60A25R"], "rxcui": ["311446"], "spl_set_id": ["5b44e248-4b7b-4777-954a-921c7b309944"], "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": "4 POUCH in 1 CASE (0990-7981-08)  / 1 BAG in 1 POUCH / 3000 mL in 1 BAG", "package_ndc": "0990-7981-08", "marketing_start_date": "20191001"}], "brand_name": "Sorbitol-Mannitol", "product_id": "0990-7981_dda87a72-d2a8-41f8-8d73-52931a149dc0", "dosage_form": "IRRIGANT", "pharm_class": ["Increased Diuresis [PE]", "Osmotic Activity [MoA]", "Osmotic Diuretic [EPC]"], "product_ndc": "0990-7981", "generic_name": "SORBITOL and MANNITOL", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sorbitol-Mannitol", "active_ingredients": [{"name": "MANNITOL", "strength": ".54 g/100mL"}, {"name": "SORBITOL", "strength": "2.7 g/100mL"}], "application_number": "NDA018316", "marketing_category": "NDA", "marketing_start_date": "20191001", "listing_expiration_date": "20261231"}