FDA.reportPublic FDA data

Mannitol

Product NDC
0409-4031
11-digit product format
004094031
Labeler code
0409
Product ID
0409-4031_4092b5ac-45f3-4404-a790-c190eb8a3545
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MANNITOL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA016269
Marketing category
NDA
Marketing start
2004-11-30
Substance
MANNITOL
Active strength
12.5 g/50mL
Pharmacologic classes
Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mannitol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MANNITOL12.5 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3OWL53L36A
Rxcui311450

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4031-01Mannitol25 in 1 TRAYINJECTION, SOLUTION2523
0409-4031-16Mannitol50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4031-01ML - Milliliter0409-4031b51ff002-9034-4202-9bc3-f067cd7cd2a612012-07-24
0409-4031-16ML - Milliliter0409-4031ad330647-8ea4-4886-801f-91f79e67ab2012016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MANNITOLACTIVE INGREDIENT3OWL53L36AMANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]12
MANNITOLACTIVE MOIETY3OWL53L36AMANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOMANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RMANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4031MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]22Current NDC, Legacy NDC, 2 package rows20241129_8ad3145e-00e7-4412-b9a5-06f00f264f30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311450mannitol 25 % in 50 ML InjectionPSN8ad3145e-00e7-4412-b9a5-06f00f264f3023
31145050 ML mannitol 250 MG/ML InjectionSCD8ad3145e-00e7-4412-b9a5-06f00f264f3023
311450mannitol 12.5 GM per 50 ML InjectionSY8ad3145e-00e7-4412-b9a5-06f00f264f3023
311450mannitol 25 % per 50 ML InjectionSY8ad3145e-00e7-4412-b9a5-06f00f264f3023
311450mannitol 25 % in 50 ML InjectionPSNe2444db1-9dfe-451f-a33c-9b00786464d26
31145050 ML mannitol 250 MG/ML InjectionSCDe2444db1-9dfe-451f-a33c-9b00786464d26
311450mannitol 12.5 GM per 50 ML InjectionSYe2444db1-9dfe-451f-a33c-9b00786464d26
311450mannitol 25 % per 50 ML InjectionSYe2444db1-9dfe-451f-a33c-9b00786464d26
311450mannitol 25 % in 50 ML InjectionPSN999ce711-2d5b-0d7d-e053-2995a90a26894
31145050 ML mannitol 250 MG/ML InjectionSCD999ce711-2d5b-0d7d-e053-2995a90a26894
311450mannitol 12.5 GM per 50 ML InjectionSY999ce711-2d5b-0d7d-e053-2995a90a26894
311450mannitol 25 % per 50 ML InjectionSY999ce711-2d5b-0d7d-e053-2995a90a26894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4031-010040940310125 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16) 2004-11-300000-00-00NoNoCurrent
0409-4031-160040940311650 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical