FDA.reportPublic FDA data

THAM

Product NDC
0409-1593
11-digit product format
004091593
Labeler code
0409
Product ID
0409-1593_c8c27324-37d9-4f12-abe7-bc3b5fbf9fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA013025
Marketing category
NDA
Marketing start
2020-06-24
Substance
TROMETHAMINE
Active strength
3.6 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROMETHAMINE3.6 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023C2WHX2V
Rxcui198412

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1593-04THAM6 in 1 CASEINJECTION, SOLUTION621
0409-1593-14THAM500 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1593-04ML - Milliliter0409-1593d3df7c42-e6a0-4f93-921d-201fd78806fc12012-07-24
0409-1593-14ML - Milliliter0409-159365f09a6f-f67f-4f76-9ac4-0e2ee7ff50e812020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROMETHAMINEACTIVE INGREDIENT023C2WHX2VTHAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]10
tromethamineACTIVE MOIETY023C2WHX2VTHAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]10
Acetic AcidINACTIVE INGREDIENTQ40Q9N063PTHAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]10
WaterINACTIVE INGREDIENT059QF0KO0RTHAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1593THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]20Current NDC, Legacy NDC, 2 package rows20241215_4af52118-c12b-4ad5-30bb-959848357e8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198412THAM 36 MG/ML in 500 ML InjectionPSN4af52118-c12b-4ad5-30bb-959848357e8a21
198412500 ML tromethamine 36 MG/ML InjectionSCD4af52118-c12b-4ad5-30bb-959848357e8a21
198412tromethamine 18 GM per 500 ML InjectionSY4af52118-c12b-4ad5-30bb-959848357e8a21
198412tromethamine 3.6 GM per 100 ML InjectionSY4af52118-c12b-4ad5-30bb-959848357e8a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1593-04004091593046 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14) 2020-06-240000-00-00NoNoCurrent
0409-1593-1400409159314500 mL in 1 BOTTLE, GLASS500 mlHistorical