FDA.reportPublic FDA data

Mannitol

Product NDC
63323-024
11-digit product format
633230024
Labeler code
63323
Product ID
63323-024_fe8beed4-a8db-400e-834e-b5efe2f5af1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MANNITOL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
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
63323-024-01Mannitol50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION504
63323-024-25Mannitol25 in 1 TRAYINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-024-25ML - Milliliter63323-02464f8dda5-5ce5-40aa-b4c8-09112372e3b712013-02-13
63323-024-29ML - Milliliter63323-024f8ca3b82-afd5-4e93-a349-0309683c0f7c12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MANNITOLACTIVE INGREDIENT3OWL53L36AMANNITOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
MANNITOLACTIVE MOIETY3OWL53L36AMANNITOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-024MANNITOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20230323_c395e13d-6ea1-4104-8b37-669cfb982f04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311450mannitol 25 % in 50 ML InjectionPSNc395e13d-6ea1-4104-8b37-669cfb982f044
31145050 ML mannitol 250 MG/ML InjectionSCDc395e13d-6ea1-4104-8b37-669cfb982f044
311450mannitol 12.5 GM per 50 ML InjectionSYc395e13d-6ea1-4104-8b37-669cfb982f044
311450mannitol 25 % per 50 ML InjectionSYc395e13d-6ea1-4104-8b37-669cfb982f044
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 startMarketing endSampleExclude flagStatus
63323-024-016332300240150 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical
63323-024-256332300242525 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01) 2000-03-190000-00-00NoNoCurrent