Sorbitol-Mannitol

Product NDC
0990-7981
11-digit product format
009907981
Labeler code
0990
Product ID
0990-7981_dda87a72-d2a8-41f8-8d73-52931a149dc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SORBITOL and MANNITOL
Dosage form
IRRIGANT
Route
URETHRAL
Labeler
ICU Medical Inc.
Application
NDA018316
Marketing category
NDA
Marketing start
2019-10-01
Substance
MANNITOL; SORBITOL
Active strength
.54; 2.7 g/100mL; g/100mL
Pharmacologic classes
Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sorbitol-Mannitol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MANNITOL.54 g/100mL
SORBITOL2.7 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3OWL53L36A, 506T60A25R
Rxcui311446

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7981-08Sorbitol-Mannitol4 in 1 CASEIRRIGANT47
0990-7981-08Sorbitol-Mannitol1 in 1 POUCHIRRIGANT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7981-08ML - Milliliter0990-7981c200ceaf-6398-4e8c-8207-e352a567685b12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7981SORBITOL-MANNITOL (SORBITOL AND MANNITOL) IRRIGANT [ICU MEDICAL INC.]5Current NDC, Legacy NDC, 2 package rows20221203_5b44e248-4b7b-4777-954a-921c7b309944.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311446mannitol 0.54 GM / sorbitol 2.7 GM in 100 mL Irrigation SolutionPSN5b44e248-4b7b-4777-954a-921c7b3099447
311446mannitol 5.4 MG/ML / sorbitol 27 MG/ML Irrigation SolutionSCD5b44e248-4b7b-4777-954a-921c7b3099447
311446mannitol 0.54 GM / sorbitol 2.7 GM per 100 ML Irrigation SolutionSY5b44e248-4b7b-4777-954a-921c7b3099447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7981-08009907981084 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG4 pouch2019-10-010000-00-00NoNoCurrent