FDA.reportPublic FDA data

Osmitrol

Product NDC
0338-0353
11-digit product format
003380353
Labeler code
0338
Product ID
0338-0353_3911fd42-2b73-4509-9c4c-92ceba4e6d34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mannitol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
NDA013684
Marketing category
NDA
Marketing start
1964-06-08
Substance
MANNITOL
Active strength
10 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
Osmitrol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MANNITOL10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3OWL53L36A
Rxcui206536, 1791395, 1791403, 1791404, 1791408, 1791409

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
0338-0353-03Osmitrol500 mL in 1 BAGINJECTION, SOLUTION50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0353-03ML - Milliliter0338-03532a2bdc99-cc36-48e6-a813-fceebf32763f12012-07-24
0338-0353-04ML - Milliliter0338-03530d95cd58-3613-4571-9e37-713a20d33be912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MANNITOLACTIVE INGREDIENT3OWL53L36AOSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
MANNITOLACTIVE MOIETY3OWL53L36AOSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
WATERINACTIVE INGREDIENT059QF0KO0ROSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0353OSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]14Current NDC, Legacy NDC, 1 package rows20250519_0d914965-7001-45cb-ba51-d7c5964b05bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791395mannitol 10 % in 500 ML InjectionPSN0d914965-7001-45cb-ba51-d7c5964b05bc16
1791403mannitol 20 % in 250 ML InjectionPSN0d914965-7001-45cb-ba51-d7c5964b05bc16
1791408mannitol 20 % in 500 ML InjectionPSN0d914965-7001-45cb-ba51-d7c5964b05bc16
206536OSMITROL 10 % in 500 ML InjectionPSN0d914965-7001-45cb-ba51-d7c5964b05bc16
1791404OSMITROL 20 % in 250 ML InjectionPSN0d914965-7001-45cb-ba51-d7c5964b05bc16
1791409OSMITROL 20 % in 500 ML InjectionPSN0d914965-7001-45cb-ba51-d7c5964b05bc16
1791404250 ML mannitol 200 MG/ML Injection [Osmitrol]SBD0d914965-7001-45cb-ba51-d7c5964b05bc16
206536500 ML mannitol 100 MG/ML Injection [Osmitrol]SBD0d914965-7001-45cb-ba51-d7c5964b05bc16
1791409500 ML mannitol 200 MG/ML Injection [Osmitrol]SBD0d914965-7001-45cb-ba51-d7c5964b05bc16
1791403250 ML mannitol 200 MG/ML InjectionSCD0d914965-7001-45cb-ba51-d7c5964b05bc16
1791395500 ML mannitol 100 MG/ML InjectionSCD0d914965-7001-45cb-ba51-d7c5964b05bc16
1791408500 ML mannitol 200 MG/ML InjectionSCD0d914965-7001-45cb-ba51-d7c5964b05bc16
1791404250 ML Osmitrol 200 MG/ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
206536500 ML Osmitrol 100 MG/ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
1791409500 ML Osmitrol 200 MG/ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
1791395mannitol 10 % per 500 ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
1791403mannitol 20 % per 250 ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
1791408mannitol 20 % per 500 ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
206536Osmitrol 10 % per 500 ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
1791404Osmitrol 20 % per 250 ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16
1791409Osmitrol 20 % per 500 ML InjectionSY0d914965-7001-45cb-ba51-d7c5964b05bc16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0353-0300338035303500 mL in 1 BAG (0338-0353-03) 500 ml1964-06-080000-00-00NoNoCurrent