Mannitol

Product NDC
84549-024
11-digit product format
845490024
Labeler code
84549
Product ID
84549-024_430669d7-9ad0-9a04-e063-6394a90ababb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MANNITOL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ProPharma Distribution
Application
ANDA080677
Marketing category
ANDA
Marketing start
2000-03-19
Substance
MANNITOL
Active strength
250 mg/mL
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
Mannitol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MANNITOL250 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3OWL53L36A
Rxcui311450

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84549-024-25Mannitol50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311450mannitol 25 % in 50 ML InjectionPSN430669d7-9ad1-9a04-e063-6394a90ababb1
31145050 ML mannitol 250 MG/ML InjectionSCD430669d7-9ad1-9a04-e063-6394a90ababb1
311450mannitol 12.5 GM per 50 ML InjectionSY430669d7-9ad1-9a04-e063-6394a90ababb1
311450mannitol 25 % per 50 ML InjectionSY430669d7-9ad1-9a04-e063-6394a90ababb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-024-258454900242550 mL in 1 VIAL, SINGLE-DOSE (84549-024-25) 50 ml2025-10-10NoNoCurrent